Cios Alpha

Operator Manual

siemens-healthineers.com
 Legend

Legend
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Provides information on how to avoid operating errors or information emphasizing
important details

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Provides troubleshooting information or answers to frequently asked questions

Indicates a list item

Indicates a prerequisite
A condition that has to be fulfilled before starting a particular operation

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Indicates steps within operating sequences

Italic Used for references and for table or figure titles

Used to identify a link to related information as well as previous or next steps

Bold Used to identify window titles, menu items, function names, buttons, and keys, for
example, the Save button

Orange Used to emphasize particularly important sections of the text

Courier Used for on-screen output of the system including code-related elements or com‐
mands

Courier Identifies inputs you need to provide

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<variable> Identifies variables or parameters, for example, within a string

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 Legend

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 Introduction 6
1.1 Use of the Product 7
1.2 Information about this Operator Manual 10

2 Safety 13
2.1 General Safety Information 15
2.2 Personal Safety 29
2.3 Equipment Safety 44

3 System Description 51
3.1 Device Description 53
3.2 System Operation 67
3.3 Emergency Situations 98

4 Examination 103
4.1 Safety information 106
4.2 Preparing the system 108
4.3 Patient registration 113
4.4 Defining the examination settings 124
4.5 Acquiring images 138
4.6 Ending the examination 151
4.7 Performing special examinations 153

5 Postprocessing 163
5.1 Patient data 165
5.2 2D image processing 175
5.3 Subtraction processing 202

6 Documentation 211
6.1 Filming/Printing 212
6.2 Exporting 216
6.3 Checking the data transfer 226
6.4 Reports 229

7 Configuration 232
7.1 User Settings 234
7.2 Examination settings (PEX Editor) 248

8 Maintenance 263
8.1 Functional and safety checks 264
8.2 Service via network connection 269
8.3 Software Update 273
8.4 Protection classes/Protection measures 276
8.5 Cleaning and Disinfection 277

9 Technical Specifications 283

9.1 Curves and diagrams 285
9.2 Precautions for EMC – 3rd Edition 304
9.3 Precautions for EMC – 4th Edition 308
9.4 Original equipment manufacturer 311
9.5 System data 312
9.6 Labels 322

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 Table of contents

10 Options 331
10.1 Advanced Security Package to protect imaging system and patient data (HIPAA) 333
10.2 Wireless WLAN network connection 337
10.3 Spacer 338
10.4 Cable for potential equalization 339
10.5 Multifunctional footswitch 339
10.6 Multifunctional footswitch, wireless 341
10.7 Remote control unit 344
10.8 Control module for the motorization package 350
10.9 Position memory for manual movements 351
10.10 Sterile cover on the C-arm 352
10.11 Sterile cover for the remote control unit 355
10.12 Sterile cover for the remote control unit cart 355
10.13 Laser light localizer 356
10.14 Active cooling 357
10.15 Energy storage unit (ESU) 357
10.16 NaviLink 2D 357
10.17 Connection for contrast agent injector 358
10.18 Video manager 360
10.19 DVI video splitter 361
10.20 "EMotion" sound system 361

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 1 Introduction

1 Introduction
1.1 Use of the Product 7
1.1.1 Intended purpose 7
Intended use 7
Indications 7
Contra-Indications 7
Patient target group(s) 7
Intended users 7
1.1.2 Clinical benefit 8
1.1.3 Undesireable side effects 8
1.1.4 Residual risk 8
1.1.5 Physical functionality 9
1.1.6 Conditions of use 9
Minimum requirements concerning hardware 9
Maintenance, cleaning and disinfection, service 10
1.1.7 Essential performance characteristics 10
1.1.8 Frequently-used operating functions 10
1.1.9 Operating functions regarding safety 10
1.2 Information about this Operator Manual 10
1.2.1 Names and parameters 10
1.2.2 Trademarks 10
1.2.3 Values 11
1.2.4 Layout conventions 11
1.2.5 Gender inclusivity 11
1.2.6 Operator manuals on the Internet 11
Accessing the operator manuals on the Internet 11
PEPconnect 12

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 1 Introduction

1.1 Use of the Product

We welcome you as a user of the powerful Cios Alpha, the multifunctional C-arm system
from Siemens Healthineers.

1.1.1 Intended purpose

Intended Purpose Statement under the European Medical Device Regulation 2017/745:
Mobile X-ray system intended for angiography- and fluoroscopic-based procedures.

Intended use
Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical
structures of patient during following clinical applications: interventional fluoroscopic,
gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic,
vascular, cardiac, critical care and emergency room procedures.

Indications
In general, all clinical indications of angiography- and fluoroscopic-based procedures
within the intended use are applicable for this device.

Contra-Indications
For this product there are currently no known contra-indications. However, contra
indications for angiography- and fluoroscopy- based procedures apply. The final decision
for use of the medical device in a certain application is made by the physician based on
his/her medical knowledge and the risks of the cases involved.

Patient target group(s)

The system can be used on all patients, from pediatric to geriatric.

Intended users
Operator profile: The usage of the system described in the Operator Manual requires
specific technical and medical knowledge and skills regarding, at a minimum, radiation
protection, safety procedures and patient safety.

People using, moving, working with the system must have acquired such knowledge and
skills during their curriculum.

Equipment training: Application training is delivered with the equipment according to

the handover contract. It is mandatory to follow such application training delivered by
Siemens Healthineers Representative before any use of the system.

The follow-up training, which is necessary due to change of personnel, is in the

responsibility of the operator of the system. Any additional training can be requested
from Siemens Healthineers.

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 1 Introduction

1.1.2 Clinical benefit

The device is a general-purpose device for interventional imaging supporting diagnostic
or therapeutic decisions by medical professionals. The device enables medical
professionals to perform angiography- and fluoroscopy- based procedures within
the intended use. Generic clinical benefits of angiography- and fluoroscopy- based
procedures within the intended use are applicable for this device.

1.1.3 Undesireable side effects

Deterministic and stochastic effects of exposure to ionizing radiation (X-rays) are part of
the physician’s medical education. The necessity of an X-ray examination in relation to
these risks must be considered by the physician when prescribing or performing such a
type of examination.

For radiation emitting products, known deterministic effects of exposure to X-rays are
erythema, cataracts, permanent epilation and delayed skin necrosis.

For radiation emitting products, known stochastic effects of exposure to X-rays are
increased risks of developing cancer and hereditary diseases.

These stochastic dose effects have an increased probability of occurrence with increased
dose. The related risk can be minimized by means of keeping the X-ray exposure to the
necessary minimum and by means of careful and systematic application of protection
measures for the operator and the clinical staff.

Examinations performed on patients especially sensitive to ionizing radiation (e.g.

infants, pregnant women, individuals with certain genetic predispositions and/or
diseases characterized by enhanced radiation sensitivity) or to contrast medium (e.g.
chronic kidney diseases) need to be planned and performed with special care to
minimize the exposure.

1.1.4 Residual risk

The Cios Alpha is a complex medical device, its functionality requires the seamless and
synchronized operation of a high number of hardware and software components, as well
as appropriate operating conditions.

A safe and effective operation of the Cios Alpha requires that it is operated by persons
with the necessary specialist knowledge and appropriate knowledge about the system,
its intended use, its functions, the conditions and limitations for its usage, periodic
maintenance and routine checks which need to be performed, the potential error
situations, as well as the corresponding recovery possibilities.

System functions may be disturbed or completely lost at any time due to component
errors, damages like ingress of liquids or collisions, or due to inappropriate operating
conditions e.g. with regards to mains power supply, excessive use of the system at
maximum load for a prolonged period of time or inappropriate maintenance or service.
User or operator behavior like using the system without appropriate care, using the
system in combination with devices, accessories, other equipment or pieces of software
in a way which is not approved by the manufacturer or cleaning or disinfecting the
system not according to the provisions given in the instructions for use may also lead
to damages or functional disturbances. Certain materials in the X-ray beam like patient
tables may impair the image quality and may lead to a higher radiation exposure.

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 1 Introduction

The Cios Alpha is designed to comply with regulatory requirements regarding

electromagnetic compatibility. It is protected against the electromagnetic influence
of external devices and does not disturb the operation of these. However, individual
external devices with emissions beyond the allowed levels or even the combined
emission of multiple, individually compliant devices may lead to the influence levels
considered in designing and testing the Cios Alpha being exceeded, and eventually,
to functional disturbances. External devices, which are not sufficiently stable against
electromagnetic influence may be disturbed by the emissions of the Cios Alpha as well.

When releasing system movements, the operator’s care is required in order to prevent
crushing, collisions with other equipment or collisions with and thus movement of
body-penetrating objects like catheters or needles.

The Cios Alpha manages radiation exposure in order to minimize the radiation dose for
the patient, user and staff, while providing the necessary level of imaging performance.
The applied dose is measured, tracked and displayed. Warnings are given under
defined conditions.

In combination with the appropriate care in the clinical workflow and informed decisions
considering also the clinical benefit of radiation, the above mechanisms should prevent
deterministic dose effects to the patient (erythema, cataracts, permanent epilation and
delayed skin necrosis). Nevertheless, such injuries cannot be completely excluded. In
rare cases, the dose management mechanisms may be not be operating correctly. These
issues are detectable for the user especially within a Quality Assurance framework. Some
clinical applications using the Cios Alpha involve injecting contrast medium into the
patient’s cardiovascular system or other body orifices. Functional disturbances in the
Cios Alpha may affect the imaging workflow resulting in the additional administration
of contrast medium. This may lead to risks and side-effects in accordance with the
information provided by the manufacturer.

1.1.5 Physical functionality

The Cios Alpha X-ray system is a compact and powerful mobile X-ray system with flat
detector and digital image processing.

The system is equipped with a footswitch and a hand switch for the release of radiation.

The following modes of operation are available in Cios Alpha for the broad scope of
applications: Single image radiography (Single Image), fluoroscopy (Fluoro), subtraction
(Sub), and roadmap (Road). In addition, digital cine mode (DCM) is available as
an option.

1.1.6 Conditions of use

The digital Cios Alpha X-ray system is a mobile system that is designed for use in the ER,
OR, and in radiology and endoscopy departments of hospitals, clinics, and outpatient
practices. The applicable country-specific requirements must be observed when using
the system.

Minimum requirements concerning hardware

The image system of Cios Alpha is being delivered, installed, and connected to the IT
environment as a complete and functioning system by our service organization.

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 1 Introduction

Maintenance, cleaning and disinfection, service

See ( Page 263 Maintenance).

1.1.7 Essential performance characteristics

See ( Page 283 Technical Specifications).

1.1.8 Frequently-used operating functions

• System On/Off

• Patient registration

• Selecting the operating mode

• Acquiring X-ray images

• Processing X-ray images (Postprocessing/Adding comments)

• Saving/archiving studies locally or to a PACS

1.1.9 Operating functions regarding safety

• Emergency stop function (Emergency stop button)

• Radiation protection (Collimator function)

• Moving the C-arm

1.2 Information about this Operator Manual

1.2.1 Names and parameters

All names and data on patients and equipment that are used as examples in this Operator
Manual are entirely fictional.

Any resemblance to names of real persons and institutions is entirely coincidental.

All parameters and images shown in this Operator Manual are examples. Only the
parameters displayed by your system are definite.

1.2.2 Trademarks
Transliner® is a registered trademark of Siemens AG.

Microsoft and Adobe Acrobat are registered trademarks, and Windows is a trademark of
Microsoft Corporation.

Oracle and Java are trademarks or registered trademarks of Oracle America, Inc.

All other product or company names mentioned in this document are trademarks or
registered trademarks of their respective owners and are used only for purposes of
identification or description.

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 1 Introduction

1.2.3 Values
All numbers specified are typical values unless specific tolerances are indicated.

1.2.4 Layout conventions

The Operator Manual has several registers. A detailed table of contents listing all
chapters contained in the manual is provided at the beginning.

Certain sections of text are marked with symbols to help you quickly identify the
information content of the text.

See ( Page 2 Legend).

1.2.5 Gender inclusivity

At Siemens Healthineers, we want to address all genders equally in our Instructions for
Use. It is not our intention to exclude anyone. We continue to update our documentation
with this in mind.

1.2.6 Operator manuals on the Internet

All operator manuals for your system are available online as PDF files in the
Document Library:

• doclib.siemens-healthineers.com
For detailed information, see: ( Page 11 Accessing the operator manuals on
the Internet)

Accessing the operator manuals on the Internet

The operator manuals for your system are available electronically on the Internet.

✓ You have the correct name and version of your system (medical device) at hand.

1 In a browser window, enter the following URL:

doclib.siemens-healthineers.com

If you are visiting this site for the first time, you will need to register and apply for
an account.

2 Follow the instructions given on the website. After logging on, you will find further
support in the Medical Imaging & Healthcare IT document category.

3 Search and filter for the required document.

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 1 Introduction

PEPconnect
PEPconnect is part of the Personalized Education Plan (PEP) Solution. It is a platform for
healthcare professionals to access and share education and performance experiences,
anytime, anywhere, on any device. The broad portfolio of medical imaging and therapy,
laboratory diagnostics, and other healthcare-related topics is available via e-learning,
competency-based training, webinars, job aids, and more.

You can find more detailed information on the webpage.

( Page 12 Using the PEPconnect platform)

Using the PEPconnect platform

1 In a browser window, enter the following URL:

pep.siemens-info.com

If you are visiting this site for the first time, you will need to register and apply for an
account in the upper right area.

2 Follow the instructions given on the website.

After logging in, you will find the material of interest by using the Search bar or the
Explore function following the path: Explore > Medical Imaging and Therapy

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 2 Safety

2 Safety
2.1 General Safety Information 15
2.1.1 Laws and regulations 15
2.1.2 Range of application 15
2.1.3 Using the system 16
2.1.4 Serious incident 16
2.1.5 Software 16
2.1.6 IT security measures 17
Operating system 17
Handling of sensitive data 17
User account information 17
Patching strategy 18
Data recovery 18
Boundary defense 18
Malware protection 18
Controlled access based on the need to know 18
Authentication/authorization controls 18
Continuous vulnerability assessment and remediation 18
Hardening 19
Network controls 19
Physical protection 19
Data protection controls 19
Auditing/logging 20
Remote connectivity 20
Incident response and management 20
2.1.7 Potential equalization 20
2.1.8 Electromagnetic compatibility 20
2.1.9 Use in connection with high frequency surgical equipment 21
2.1.10 Maintenance and inspection 21
Wear and tear 21
Image quality 21
Calibration 22
Performing maintenance 22
Acceptance and performance testing, acceptance criteria 22
2.1.11 Malfunctions 22
Error messages at the C-arm system 22
System messages on the monitor 23
Handling error messages 24
2.1.12 Malfunction of electrical systems 24
System failure 25
Switching to emergency power supply 25
Disconnecting the power plug 26
2.1.13 EMERGENCY STOP 26
Press the EMERGENCY STOP button 26
Unlocking the EMERGENCY STOP button 27
2.1.14 Fire protection 27
2.1.15 Explosion protection 28
2.1.16 Overload protection 28
2.2 Personal Safety 29
2.2.1 Open heart and skull examinations 29
2.2.2 Crushing hazards on the C-arm system 29
2.2.3 Mechanical damage 31

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 2 Safety

2.2.4 Radiation protection 31

For the patient 31
For the operating personnel 32
For patients and operating personnel 32
Deterministic radiation effect 33
Location and size of the relevant operating areas 33
Radiation interruption for all operating modes 44
2.3 Equipment Safety 44
2.3.1 Mechanical safety 44
2.3.2 Positioning the C-arm 44
Brakes 44
Transport 45
2.3.3 Installation, repair 45
2.3.4 Original accessories 45
2.3.5 Combination with other systems 46
2.3.6 Attachment of dedicated options 46
General safety requirements 46
Attenuation equivalent 46
Weight counterbalance 47
Image quality 47
Electrical safety 47
Electromagnetic compatibility 47
Attaching navigation systems 48
Additional safety information 49
2.3.7 Disposal 50

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 2 Safety

2.1 General Safety Information

2.1.1 Laws and regulations

If legally binding regulations govern the installation and/or operation of the system, it is
the responsibility of the installer and/or the operator to observe these regulations.

Regulations required by law and the radiation protection regulations must be observed
in all countries. Deviating from this Operator Manual, values may be set according to
country-specific regulations.

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. Devices of the type Cios Alpha that
comply with these guidelines have the serial numbers from 40000 to 40299 and from
41000 to 41999.

This device bears a CE mark in accordonce with the provisions of EU Regulation 2017/745
of April 5, 2017 concerning medical devices and the Council Directive 2011/65/EU of
June 8, 2011 on the restriction of the use of certain hazardous substances in electrical
and electronic equipment. Devices of the type Cios Alpha that comply with these
guidelines begin with the serial number from 40300 to 40999 and the serial number
starting from 42000.

Data related to individual persons are subject to data protection. Please comply with the
applicable legal regulations.

Legally required tests must be performed at the specified intervals. These tests include,
for example,

• Constancy test according to the X-ray ordinance (§115 StrlSchG) in the Federal
Republic of Germany.

• Tests based on DHHS guidelines (Department of Health and Human Services)

where applicable.

Siemens Healthineers hereby certifies that the Cios Alpha is compliant with the
recognized consensus standards covering electrical and mechanical safety, which are
listed in the declaration of conformity in its current valid version.

2.1.2 Range of application

This Operator Manual is valid for the following product:

• Cios Alpha
This Operator Manual is valid for the following system software versions:

• Software Full Version: VA30G and higher, for example VA30H

• Software Release Version: VA30

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 2 Safety

2.1.3 Using the system

CAUTION

Improper use of the system beyond its intended use.

Risk to the patient and user!

◆ The system may only be used as defined by its intended use for
clinical applications.

WARNING

System operation by untrained users.

Misinterpretation of image information or of indications of the system,

leading to inappropriate decisions in the clinical workflow, incorrect diagnosis
or treatment, delay of the clinical procedure, or exposure to radiation without
clinical benefit.

◆ Only persons with the required knowledge and expertise who have undergone
the appropriate user training may work with the system.

CAUTION

Occurrence of audible signals.

Hazards possible, for example due to crushing risks, extended radiation

release, and high dose rate.

◆ Please note that continued system operation may lead to one of these hazards.
◆ Use the system with extreme caution to avoid these hazards.

2.1.4 Serious incident

According to EU regulation 2017/745 (MDR), any serious incident that has occurred
in relation to the device should be reported to the manufacturer and the competent
authority of the EU member state in which the user and/or patient is established.

2.1.5 Software
The system and user software used in this product is protected by copyright. The current
software version is displayed on screen during system start-up.

WARNING

Use of unreleased or altered software or hardware components.

Risk of malfunction that could endanger the patient or product.

◆ Only use Siemens Healthineers-authorized software and hardware components.

◆ Only perform repairs, or have them performed by an authorized third party, after
having received our express written approval.

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 2 Safety

CAUTION

Unauthorized or incorrect alterations/changes of the software or connection of the

system to a network.

Risk of unauthorized access.

◆ Make sure that all necessary precautions are taken with regard to the applicable
security level if a functionality is added or the configuration of the condition on
delivery is changed.

CAUTION

Unauthorized changes or interventions in the imaging system.

No or improper function of the imaging system.

◆ Do not perform any changes or interventions of any type on the imaging system
without the written consent of Siemens Healthcare (supplier). This includes
replacing hardware or installing and running additional software.

The pre-installed security package provides protection against cyber attacks, viruses,
malware and other damaging software. It ensures that only trusted applications are run
on the systems. It blocks unauthorized access, provides protection from network threats
and infected USB sticks and thus offers control over when and who may make changes.

In order to receive software updates, the system must be switched on and connected to
the network on a regular basis. If the system is equipped with WLAN, the WLAN option
must be activated.

We recommend switching on the Cios Alpha at least once per week and connecting it
to the LAN (or WLAN if available) network for 3 hours.

2.1.6 IT security measures

Operating system
Cios Alpha is based on Windows 10 Enterprise 2016.

Handling of sensitive data

The Cios Alpha components maintaining sensitive data (other than removable media)
are physically secure, i.e. cannot be removed without tools.

Additionally, secured equipment disassembly at the end of the product lifecycle ensures
secured and definite destruction of all sensitive data.

User account information

The system supports compliance to HIPAA (Health Insurance Portability and
Accountability Act) regulation with role based privilege assignment and access control.
The security option must be procured to enable user management on application level.

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 2 Safety

Patching strategy
Siemens Healthineers performs vulnerability monitoring of the included third party
components (including the operating system). Vulnerabilities are assessed regarding
their criticality and safety relevance. In case of critical vulnerabilities the associated
hotfixes are distributed within a system service pack.

Service packs can be either installed remotely or on site by the trained Siemens
Healthineers service technician - depending on the availability of the remote service
infrastructure at the customer's site and on the impact of the service pack. Siemens
Healthineers provides hotfixes on a regular base.

Cybersecurity advisories and bulletins for Siemens Healthineers equipment are issued by
the Siemens Product CERT (Computer Emergency Response Team).

Data recovery
It is assumed that Personal Health Information (PHI) is archived to a PACS after patient
scan was completed or images/reports are ready after post processing.

The system supports backup and restore of system configuration to an external drive.

Boundary defense
Built in firewall is used to minimize the network attack surface. For optimized protection
of sensitive data and operation of the system it must be deployed in a secure network
environment, utilizing e.g. network segmentation, client access control and protection
against access from public networks.

Boundary defenses in the hospital should be multilayered relying on firewalls, proxies,

DMZ and network based IDS and IPS.

Malware protection
Microsoft Device Guard (Windows 10)

Controlled access based on the need to know

The system supports HIPAA standard with role based privilege assignment and access
control. The security option must be procured to support this.

Authentication/authorization controls
The system security option provides the following controls:

• Role-based access control implemented via Windows Local Policy setting

Continuous vulnerability assessment and remediation

See ( Page 18 Patching strategy)

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 2 Safety

Hardening

• Microsoft Device Guard protects against malware

• Microsoft Device Guard is also used to ensure installed software/update is

manufacturer-authorized software or update

• Microsoft Firewall minimizes attack surface

• All accounts not required for the intended use of the Cios Alpha are disabled or
deleted, for both users and applications

• All shared resources (e.g. file shares) not required for the intended use of the Cios
Alpha are disabled

• All communication ports not required for the intended use of the Cios Alpha are
closed/disabled (see Section Network Information)

• All services not required for the intended use for the Cios Alpha are deleted/disabled
(see Section Network Information)

• All 3rd party software as well as OS-included applications not required for the intended
use of the Cios Alpha are deleted/disabled (see Section Software Bill of Materials)

• the system prohibits boot from removable media via password protected BIOS settings

Network controls

• Microsoft Firewall: Firewall rules are configured so that inbound connections from
devices are restricted to minimize the attack surface

• Siemens Healthineers recommends operating the system in a secured network

environment, e.g. a separate network segmented or a VPN. Connection to the Internet
is discouraged and may limit the liability of Siemens Healthineers in case of incidents.

• In case of a denial of service (DoS) or malware attack, the system can be taken off the
clinical network and operated offline. Exchange of clinical result would then require an
active offline media (DICOM CDR or DVDR) function.

Physical protection
The Cios Alpha components maintaining sensitive data (other than removable media)
are physically secure, i.e. cannot be removed without tools.

Data protection controls

• The system ensures integrity of stored data.

• The system restricts health data transmission to configured DICOM nodes only.

• PHI data is protected by role based access control. The security option must be
procured to support this.

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 2 Safety

Auditing/logging
The system security option provides the auditing for the following events: login/logout

• Unsuccessful login attempt

• Creation/modification/deletion of patient and image data (including data received

from the RIS)

• Start/end of image acquisition with timestamp

• Storage of images in a study

• Start/close of examination

• Sending of images (including destination, amount, mode, etc.)

With Smart Remote Services

• Remote service activity

Remote connectivity
The following technical and organizational measures help minimize the risk of
unauthorized access through remote services (SRS):

• Network separation, secured connection, and access control to protect

customer network

• Multi-factor authentication procedure

• Country-specific authorization

• User on medical device controls access mode

• Optional: access log available to customers

• Optional: immediate email when access starts/stops

Incident response and management

See ( Page 18 Patching strategy)

2.1.7 Potential equalization

Your system offers the possibility of a potential equalization so that all components have
the same potential.

2.1.8 Electromagnetic compatibility

This medical device complies with the requirements of the applicable standard on
electromagnetic compatibility (EMC). See ( Page 304 Precautions for EMC – 3rd Edition)
and ( Page 308 Precautions for EMC – 4th Edition)

Please be advised that other mobile electronic devices, e.g. cellular telephones,
exceeding the established emissions limits in the EMC standard may disrupt the
functions of your medical device.

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 2 Safety

WARNING

Interference.

Impact on the patient's electronic life-sustaining systems.

◆ In case of unusual system behavior (performance characteristics), additional

measures (adjustment, repositioning) may be required.

2.1.9 Use in connection with high frequency surgical equipment

The following regulations for use must be observed:

• IEC/TR 61289 Ed. 2.0:2019-05

High frequency surgical equipment and high frequency surgical accessories -
Operation and maintenance

2.1.10 Maintenance and inspection

Before using the equipment for examination, the user must ascertain that all safety-
relevant devices function properly and that the system is ready for operation.

Wear and tear

The system is subject to mechanical and electrical wear and tear. In the interest of
the safety of patients, operating personnel and third persons, maintenance and safety
checks must be carried out every 24 months to maintain the operational safety and
reliability of the product.

CAUTION

Wear and tear.

Risk of injury to the patient, operating personnel, and other persons.
Permanent damage to the system.

◆ Follow the maintenance guidelines to maintain the safety and functionality of

the system.

Please observe the relevant information in ( Page 263 Maintenance).

Image quality
Maintenance should include checking the image quality. Maintenance at regular
intervals is recommended to always ensure best image quality.

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To ensure optimal image quality, have the following functions checked in particular as
part of regular maintenance:

Pixel shift, image rotation, noise reduction, edge enhancement, subtraction,

roadmapping, noise filter.

Calibration
Maintenance should include checking the flat detector calibration.

Performing maintenance
Maintenance work should be performed by trained technical personnel only. If
you do not have a maintenance contract, please contact Siemens Healthineers
Customer Service.

If national laws or regulations specify more frequent inspection and/or maintenance,

these must be observed.

Acceptance and performance testing, acceptance criteria

During system installation and after major modifications an acceptance test is carried out
by qualified and authorized engineers. The corresponding acceptance criteria and test
results are documented in a protocol on site.

2.1.11 Malfunctions
In the event of malfunctions of the Cios Alpha system, please call Siemens Healthineers
Customer Service.

Error messages at the C-arm system

When a malfunction is detected, the Cios Alpha system is disabled. The problem is shown
as an error on all control units.

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A message window with additional explanations is also displayed on the left monitor
( Page 23 System messages on the monitor).

System messages on the monitor

On the left monitor (upper left), three different types of system messages can appear.
The type of message is identified by a corresponding symbol (top).

Error message:

Warning:

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Information:

Handling error messages

✓ An error message window is displayed.

Acknowledging 1 Please read the error messages carefully. Use the scroll bars to display error messages
error messages outside the area currently displayed.

2 Acknowledge the error message by clicking OK or pressing the footswitch or

hand switch.

If you cannot continue with the normal examination mode, contact Siemens
Healthineers Customer Service.

Repeatedly occurring errors If errors occur repeatedly, switch off the Cios Alpha and notify Customer Service. Save the
log file with the logged system activities beforehand:

1 Right-click this icon on the lower left of the left monitor.

2 In the dialog box, select the storage destination (USB and/or local storage for analysis
via remote diagnostics) and confirm with OK.

3 Additionally, write down the following information:

Error number and time when error occurred.

Operating mode selected.

Was radiation activated when the error occurred?

Is the error related to an operating process?

4 In the case of a malfunction or failure of the radiation indicator, please notify Siemens
Healthineers Customer Service.

2.1.12 Malfunction of electrical systems

In case of risks for patients and operators (e.g. if there is no live image on the monitor
and the radiation indicator is on despite this) or in case of risks for the device, you
must disconnect the power plug immediately. Cios Alpha is completely shut down and
disconnected from line power. This

• switches off radiation

• aborts the current system program

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• aborts and cancels current operating sequences

• deletes all image information not saved to a hard disk

CAUTION

Technical error.

Unintentional radiation release.

◆ If the unintentional radiation release cannot be ended with the EMERGENCY

STOP button, press the off switch to shut down the entire system.

Only after the cause of the hazard has been clearly identified and remedied may the
system be reconnected to the power supply. In all other cases, e.g. system malfunction,
contact Siemens Healthineers Customer Service immediately.

CAUTION

Failure of LED indicators on the control panel.

Treatment not possible.

◆ Perform the daily function check of the LED indicators before
beginning treatment.
◆ If an LED indicator fails, contact Siemens Healthineers Customer Service.

System failure
The user must have a replacement unit available if a system failure could predictably
cause a critical situation resulting in patient injury during a medical examination.

WARNING

Due to the complexity of the system and related system component failures
or disturbances in the mains power supply, e. g. line voltage is outside of the
designated specification, it cannot be entirely excluded that system functions
including X-ray imaging or other system functions get disturbed or unavailable.

Disturbance or unavailability of system functions. Interventions cannot be

started or continued!

◆ Consider therefore the need to establish emergency procedures to manage

situations related with the failures of the system, e. g. keeping a reserve
system available.

Switching to emergency power supply

In the event of a power interruption of longer than 10 ms, the Cios Alpha switches off. In
this case the Cios Alpha must be switched on again after the system has switched over
to the emergency power supply.

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Disconnecting the power plug

After the power plug is disconnected, the uninterruptible power supply (UPS) supplies
voltage to the imaging system and the left-hand monitor until the Cios Alpha switches
off completely.

WARNING

Unsuitable devices connected to the UPS.

Risk of electrical shock or damage to the system.

◆ Do not connect any additional devices to the UPS sockets.

2.1.13 EMERGENCY STOP

Press the EMERGENCY STOP button

Immediately press the red EMERGENCY STOP button (arrow) on the C-arm system control
unit at the first sign of a dangerous situation resulting from motorized movement.

• Motorized vertical lift and motorized orbital and angular movements are
disabled immediately.

• The electromagnetic brakes are locked.

• Active radiation is terminated.

• All other system functions remain unaffected by this.

CAUTION

Emergency stop not functional.

Risk of crushing and collision for persons and objects in the vicinity of
moving parts.

◆ Check the EMERGENCY STOP function on a daily basis.

CAUTION

Position of EMERGENCY STOP button not known.

In an emergency, the EMERGENCY STOP button will not be actuated in a
timely manner.

◆ Make sure you know where the EMERGENCY STOP buttons are located.
EMERGENCY STOP buttons are in the following locations (see the figure).

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Emergency Stop button

If during an examination an error occurs and radiation cannot be interrupted by

releasing the trigger switch, press the EMERGENCY STOP button on the chassis of the
C-arm system or on the remote control unit (optional).

Unlocking the EMERGENCY STOP button

Unlock the button only after the danger has clearly been eliminated.
◆ To unlock the button, gently turn it clockwise so that it pops back out.

2.1.14 Fire protection

WARNING

Fire in or near the system.

Injury to patient and personnel, and damage to device. Risk of gas poisoning
due to burning plastic.

◆ In case of fire switch off the system.

◆ Be aware of and inform patients of escape routes.
◆ Be aware of where fire extinguishers are located and know how to use them.

Please inform our Customer Service prior to starting up the Cios Alpha again if repair
work has to be performed due to the fire.

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2.1.15 Explosion protection

WARNING

The system is not designed for operation in explosion-endangered areas. It does

not fulfill the requirements for AP/APG classification.

Explosion hazard!

◆ The system may not be used in locations where explosive atmospheres

may occur.

2.1.16 Overload protection

Prolonged continuous radiation at maximum tube load is possible in fluoroscopy mode.
However, this can cause the X-ray tube assembly and C-arm to heat up. For this reason,
the X-ray tube assembly and C-arm have a thermal monitor. If the X-ray tube assembly
is too warm, there may be a reduction in pulse rate if necessary in all operating modes
beginning with the next scene. If the C-arm temperature rises to ≥ 40 °C, the following
message is displayed:

When Yes is selected, the C-arm temperature can rise to 48 °C. This extends system
availability. There is no impact on function until 48 °C is reached.

When No is selected, the maximum permitted temperature for the C-arm (41 °C) is not
increased. This causes the device to reach maximum temperature sooner and reduce the
frame rate sooner.

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CAUTION

Under extreme operating conditions (continuous operation close to the maximum

tube voltage), the X-ray tube can become very hot. This can shorten the service life
of the system components.

Risk of burns and prolongation of the operation!

◆ Avoid touching the X-ray tube housing.
◆ Change your parameter settings, e.g. by reducing the dose level.
◆ Please make sure that the system has cooled down before performing critical
interventional applications.
◆ We also recommend keeping a second system ready for continuous radiation
lasting longer than 30 minutes.

A constant X-ray tube load can lead to temperature-related cutoff of the radiation.
Please make sure that the system has cooled down before performing critical
interventional applications. We also recommend keeping a second system ready
for continuous radiation lasting longer than 30 minutes.

In the rare event image display is delayed due to high system utilization, radiation
is automatically turned off. To continue treatment, radiation release has to be
actuated again.

If the Radiography mode is misused for real-time imaging on purpose by the operator,
the delay of the image display may be longer than in Radioscopy.

2.2 Personal Safety

2.2.1 Open heart and skull examinations

If an approved system is used alone or with other equipment for open heart or open
skull examinations, a conductive connection must be made between the system and an
external potential equalization terminal, e.g. the tabletop. ( Page 69 Establishing the
connection for potential equalization)

Only then can the patient be connected to the system.

2.2.2 Crushing hazards on the C-arm system

Correct handling of the C-arm system requires that operating personnel and patients use
only the handles provided for this purpose. Where this is not possible, monitor the points
of potential crush injury between movable system parts and their guide openings.

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CAUTION

The distance between the patient or other persons and the system is too small.

Risk of crushing!

◆ Use the system only if the patient and other persons can be observed
during movements.

CAUTION

The points marked on the figure indicate hazardous locations around the system.

Risk of injury to the patient and personnel due to crushing or collision.

◆ Be careful around the hazardous locations indicated.

CAUTION

The distance between the handles and other components is too small.

Risk of crushing!

◆ Be careful around the hazardous locations indicated.

CAUTION

Movements of the C-arm during patient positioning.

Crushing hazard for the patient!

◆ Be careful around the hazardous locations indicated.

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Hazardous locations during C-arm movements

2.2.3 Mechanical damage

To avoid injury to the patient, operating personnel or third parties, mechanical damage
to the system must be repaired by authorized service personnel.

2.2.4 Radiation protection

The unit is intended for procedures that may involve high skin doses when it is used
as intended (mainly due to the long examination times), which presents a risk of
radiation injury.

Therefore observe the following important notes in order to keep the dose absorbed by
the patient as low as possible.

For the patient

• Keep the radiation field as small as possible without reducing the active
measuring field.

• If possible, ensure the best possible protection of the patient during fluoroscopy and
acquisitions in the vicinity of his or her reproductive organs (use gonadal shields,
ovarian shields and lead rubber covers).

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• Remove all radiopaque parts from the fluoroscopy field or field of view, if possible.

• Set the voltage of the X-ray tube as high as necessary (note the image
quality, however).

For the operating personnel

• Wear protective clothing in the control area during an examination: Depending on

the application involved, the use of lead vests, lead jackets, X-ray protection goggles,
sternum protection and protective gloves is recommended.

For patients and operating personnel

• Keep the fluoroscopic time as short as possible.

• Set the tube-skin distance as high as can be justified for the respective examination.

CAUTION

Because of a technical error the acquisition is not stopped or there is an unintended

release of radiation.
Risk of unnecessary radiation exposure!
◆ In the event of unwanted radiation, press the nearest EMERGENCY STOP button.

CAUTION

Failure of radiation indicator.

Danger of unintended radiation!

◆ If a radiation indicator fails contact Siemens Healthineers Customer Service.

CAUTION

Additional objects in the beam path.

Risk of unnecessary radiation exposure!

◆ Note that additional objects in the beam path (e. g. components from external
navigation systems) increase scatter radiation. Remove them when not needed.

Please be aware that certain materials in the X-ray beam (e.g. parts of an operating
table) may impair the X-ray image due to imaging of contours and inclusions in these
materials. In certain rare cases, this may lead to incorrect diagnosis. This material may
also result in higher radiation exposure.

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Cios Alpha contains no patient positioning aids. Therefore, undertable radiation

protection options are not included in the scope of supply. For example, overhanging
lead rubber mats can be used to protect against scattered radiation underneath the
patient table.

Deterministic radiation effect

As per IEC 60601-1-3, 5.2.4.5 (A.2), deterministic radiation injury is possible if a
radiation dose delivered to an organ or tissue exceeds a value of 1 to 3 Grays.

With typical applications and proper use of the C-arm, there is no reason to expect such
radiation injuries. It is assumed that the maximum fluoroscopic time will not exceed 20
minutes, depending on the application, and that the skin entrance point will be 30 cm
(50 cm maximum) away from the detector input.

Example: An accumulated fluoroscopic time of 20 minutes and a skin entrance dose of

20 mGy/min yields a dose of 400 mGy.

In the medical disciplines of vascular and cardiac surgery in particular, several

applications require a significantly higher radiation time of up to 60 minutes.

Example: When treating an abdominal aortic aneurysm (AAA) with the Endovascular
Aortic Repair (EVAR) procedure, the administered radiation dose can exceed 1 Gy. The
average radiation dose when using this method is usually less than 500 mGy.

For procedures with a longer than expected radiation time, we recommend varying the
beam direction (oblique beam through orbital and/or angular rotation) during the course
of the procedure. In addition, the system reports the beam duration that has already
been applied (regardless of applied dose).

The skin penetration dose for various operating modes and under standard
operating conditions can be estimated using the "Dosimetric information" table
( Page 292 Dosimetric information).

When changing the distance from the skin penetration point to the focus, please note
that the skin dose decreases with the inverse square of the distance to the focus.
This means that when the distance to the focus is halved, the skin penetration dose
rate quadruples.

CAUTION

Remaining in hazardous area.

Danger of inadvertent radiation!

◆ During radiation release, make sure you are in a location subject to as little
radiation as possible.

Location and size of the relevant operating areas

All examination types may be performed in the illustrated operating areas of the
X-ray system.

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X-ray tube assembly at the

bottom

Maximum scatter radiation in Scatter radiation in the main operating area according to IEC 60601-1-3
operating area

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Tolerance of the air kerma measurements ± 5%

(1) Measurement A
(2) Measurement B

Measurement A

• Measurement A1
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement A2

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

Measurement B

• Measurement B1
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement B2

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

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X-ray tube assembly at the top

Maximum scatter radiation in Scatter radiation in the main operating area according to IEC 60601-1-3
operating area

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Tolerance of the air kerma measurements ± 5%

(1) Measurement A
(2) Measurement B

Measurement A

• Measurement A1

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement A2
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

Measurement B

• Measurement B1

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement B2
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

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Detector, lateral 42°

Maximum scatter radiation in Scatter radiation in the main operating area according to IEC 60601-1-3
operating area

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Tolerance of the air kerma measurements ± 5%

(1) Measurement A
(2) Measurement B

Measurement A

• Measurement A1
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement A2
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

Measurement B

• Measurement B1
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement B2

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

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X-ray tube assembly lateral

45°

Maximum scatter radiation in Scatter radiation in the main operating area according to IEC 60601-1-3
operating area

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Tolerance of the air kerma measurements ± 5%

(1) Measurement A
(2) Measurement B
Measurement A

• Measurement A1
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement A2

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

Measurement B

• Measurement B1
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement B2
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

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X-ray tube assembly

horizontal

Maximum scatter radiation in Scatter radiation in the main operating area according to IEC 60601-1-3
operating area

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Tolerance of the air kerma measurements ± 5%

(1) Measurement A
(2) Measurement B
Measurement A

• Measurement A1

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement A2
Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

Measurement B

• Measurement B1

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

• Measurement B2

Fluoroscopy 125 kV, 20 mA, 13.3 ms, 15 p/s, 18 cm x 18 cm

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Radiation interruption for all operating modes

The hand switches and footswitches are designed as pushbutton switches. Radiation is
interrupted in fluoroscopy when releasing the corresponding operating element or, in
other operating modes, after acquiring the stored image.

2.3 Equipment Safety

2.3.1 Mechanical safety

CAUTION

System component error.

An error on one system component can reduce the safety of the entire system.
◆ Terminate system operation.
◆ Contact Siemens Healthineers Customer Service.

CAUTION

Image intensifier / flat detector cover broken.

Skin or eye irritation, irritation of the breathing passages, toxic or allergic
reactions caused by contact with hazardous substances!
◆ If the image intensifier / flat detector cover is broken, do not touch the detector,
do not use the system at all.
◆ Please call Siemens Healthineers Customer Service.

WARNING

Spindle nut broken or worn.

Risk of crushing!
◆ Vertical lift is blocked if the mechanical safeguard was triggered. Contact
Siemens Healthineers Customer Service to replace the mechanical safeguard.

2.3.2 Positioning the C-arm

In case of improper handling of the Cios Alpha, the mobility of the C-arm may lead to
collisions of the flat detector and the single tank with the patient and the patient table.

Brakes
Make sure the brakes are applied after adjusting the C-arm position.

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Transport
When moving or transporting the C-arm system please take special care that the system
parts do not collide with an obstacle. This could also result in accidental radiation release
or an impairment of image quality under certain circumstances.

CAUTION

Transport damage.

Risk of injury!
◆ Carry out professional repairs only, otherwise consequential damage to the
product cannot be ruled out!

2.3.3 Installation, repair

Modifications of or additions to the product must be made in accordance with the legal
regulations and generally accepted engineering standards.

As the manufacturer, Siemens Healthineers cannot accept responsibility for the safety
features and for the reliability and performance of the equipment if:

• The product is used in a manner other than that specified in the Operator Manual

• Installation, upgrades, readjustments, modifications or repairs are performed by

personnel not contracted and authorized by Siemens Healthineers

• Components affecting safe operation of the product are not replaced by original spare
parts in the event of a malfunction

• The electrical wiring in the room containing the system does not meet the
specifications of DIN VDE 0107 and the corresponding local regulations

If desired, we will provide the technical documentation for the product. However, this
does not imply authorization to undertake repairs.

We cannot be held responsible for repairs made without our express written approval.

When any work is performed on the product, we recommend that you obtain a certificate
indicating the nature and scope of the work performed. The certificate should include
any changes in rated parameters or operating ranges as well as the date, the name of the
company and a signature.

2.3.4 Original accessories

For safety reasons, only approved original accessories or non-Siemens Healthineers
accessories approved by Siemens Healthcare GmbH, may be used for this product.

The operator is liable for any risks associated with the use of accessories not-approved
by Siemens Healthineers.

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CAUTION

Inappropriate accessories.

The use of accessories that do not comply with the safety requirements of this
equipment can reduce the safety of the entire system.

◆ Use only original Siemens Healthineers accessories or accessories approved by

Siemens Healthineers.

2.3.5 Combination with other systems

To ensure the required safety, only products/components expressly approved by Siemens
Healthcare GmbH may be used in combination with this system.

Please note that changes to the system may be carried out only with the express
authorization of Siemens Healthcare GmbH.

Additional components placed into the beam path (for example, positioning aids) will
attenuate radiation and can degrade image quality.

2.3.6 Attachment of dedicated options

The attachment of certain (dedicated) options is permitted only if the following
conditions are met:

General safety requirements

The use of accessories that do not comply with the relevant safety requirements of this
system can result in a reduced safety level of the combined system.

When choosing accessories, the following aspects must be considered in particular:

• Use of accessories close to the patient.

• Proof that the accessories have been safety tested according to the applicable IEC
60601-1 guideline and/or the IEC 60601-1 harmonized national standard.

WARNING

Changing of the overall center of gravity.

Risk of crushing!

◆ Only products/components approved by Siemens Healthineers may be installed.

Attenuation equivalent
According to IEC 60601-1-3, inadequate attenuation of the X-ray beam by materials
between the patient and image receptor must be avoided.

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Documented proof by the manufacturer is recommended.

Remove any auxiliary devices located in the beam path for calibration or adjustment of
the dedicated options before operating the Cios Alpha.

Image quality can be impaired by placing materials directly in front of the flat detector,
or the applied dose is increased by the automatic adjustment. Additional objects in the
beam path may result in increased scattered radiation.

Weight counterbalance

CAUTION

Changing the weight distribution

Risk of crushing!
◆ Adding weight to the detector or single tank side means a loss in counterweight
and can result in unintended movement of the C-arm.

Users must be alerted to the loss of counterbalance by a warning label. The responsibility
for affixing the corresponding warning label lies with the company that attaches the
dedicated option to the C-arm.

Image quality
The attachment of a dedicated option must not affect image quality (impairment of
the follow-up).

After maintenance or service work, the correct function of the non-Siemens

Healthineers system on the detector must be tested.

Electrical safety
IEC 60601-1, Section 3, “Protection against electric shock hazard” must be
complied with.

Electromagnetic compatibility
IEC 60601-1-2 must be observed in order to comply with the limit values for
electromagnetic compatibility.

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Attaching navigation systems

CAUTION

Additional weight after installing components for navigation.

Risk of injury!

◆ Note that the C-arm is no longer balanced after additional components are
attached. It can move on its own after brakes are released.

WARNING

Heavy weight of external navigation components.

Risk of injury!

◆ Note that stability in accordance with DIN EN/UL standards is guaranteed only if
the external system (navigation) on the detector does not exceed the calculated
maximum weight.

CAUTION

Overloading the C-arm.

Risk of injury!

◆ Note that the braking action is guaranteed only if the external system
(navigation) on the detector does not exceed the calculated maximum weight.

CAUTION

Sharp edges.

Risk of injury!

◆ Be careful of any sharp edges on the externally attached navigation system.

CAUTION

Incorrectly attached navigation system.

Risk of injury!

◆ Before navigation-assisted operation, the user must ensure sufficient accuracy

of the navigation system.

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CAUTION

Contaminated or defective detector interface.

Insufficient navigation accuracy, risk of injury!

◆ Prior to using the navigation system check the required cleanliness

and functionality.

WARNING

Use of insufficiently electrically-protected external navigation components.

Risk of injury!

◆ Use only approved accessories and combined devices.

Additional safety information

• To avoid thermal overloading of components and short circuits, IEC 60601-1 Section
7 must be complied with.

• Connecting external loads to the power supply of the C-arm system is not permitted.

• We recommend that users in the EU have the relevant manufacturer of the accessory
operated by you confirm the CE Declaration of Conformity according to Appendix
II, MDR (EU Regulation 2017/745 of April 5, 2017) concerning medical devices and
the Council Directive 2011/65/EU of June 8, 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic devices, and the Declaration
of Compatibility according to Article 22, MDR. In countries outside the EU the relevant
national regulations must be observed.

• When putting the C-arm system into operation together with other devices,
ensure that the following requirements from IEC 60601-1, section 16 are met:
16.6.1 TOUCH CURRENT, 16.6.3 PATIENT LEAKAGE CURRENT, 16.9.2.2 PROTECTIVE
EARTH CONNECTIONS.

• Joint connection to the power supply of the C-arm system together with other devices
using a multiple socket is not permitted.

• Conductors connecting the C-arm system with other devices must be protected
against mechanical damage.

• Only devices approved for this purpose by Siemens Healthineers may be connected to
the NaviLink Ethernet interface.

• The connection to the NaviLink Ethernet interface may only be made using a shielded
(S/FTP) Ethernet cable that complies with the relevant standards.

• The length of the Ethernet cable must not exceed 10 m.

The product liability and warranty are restricted or expire if the above listed conditions
and limit values are not complied with when attaching accessories.

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For non-Siemens Healthineers options we generally accept no liability.

2.3.7 Disposal

• If you want to remove the product from service, take into consideration that public
legal directives may contain special regulations regarding disposal of this equipment.
In order to ensure that these legal regulations are complied with and to avoid potential
environmental hazards which may be caused by the disposal of your system, please
consult Siemens Healthineers Customer Service.

• Batteries and packaging material must be disposed of in an environmentally safe

manner according to national regulations.

• The sterile single-use covers must be disposed of in accordance with national

regulations or the rules of the hospital.

• For further information about the disposal of the product, please refer to our
service documents.

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 3 System Description

3 System Description
3.1 Device Description 53
3.1.1 System overview 53
Standard equipment 53
Options 54
3.1.2 C-arm system 56
Flat detector with anti-scatter grid 56
Single tank 57
Dose measuring chamber (DAP meter) 57
3.1.3 Monitor trolley 59
UPS display field 59
3.1.4 Control elements 61
Control unit on the C-arm system 61
Control panel on the monitor trolley 62
Hand switch 63
Footswitch 63
3.1.5 Operating modes 64
Fluoroscopy 64
Single image 65
Digital Cine Mode (optional) 65
Subtraction/Roadmap (optional) 65
3.1.6 Description of image processing 66
3.1.7 Image display 66
3.2 System Operation 67
3.2.1 Start-up 67
Connecting the C-arm system with the monitor trolley 67
Connecting the footswitch 68
Establishing the connection for potential equalization 69
Establish the power line connection 69
Switching on the Cios Alpha 70
Functions during system start-up 70
3.2.2 Move C-arm 72
Operating the brakes 73
Lifting and lowering the C-arm 74
Moving the C-arm horizontally 75
Swivelling the C-arm 76
Angulating the C-arm 77
Orbital movement of the C-arm 78
3.2.3 Control panel 79
Exposure parameters 80
Task cards 81
Control elements 82
Submenus 83
Keyboard mode 84
Enlarged preview image (blow-up) 85
Changing settings in enlarged preview 86
3.2.4 Operating the hand switch 86
Radiation release 86
Image storage 87
Storage 87

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3.2.5 Operating the footswitch 87

Radiation release 87
Image storage 88
3.2.6 Switching off 88
Switching off the system completely 89
Switching off the C-arm system only 89
Disconnecting Cios Alpha from line power 90
Reactivating the system 91
3.2.7 Transporting the C-arm system 91
Preparing the C-arm system 91
Drive operation and steering of the C-arm system 92
Braking the C-arm system 93
C-arm system park position 94
3.2.8 Transporting the monitor trolley 94
Preparing the monitor trolley 94
Moving the monitor trolley 95
Locking the monitor trolley 95
Setting the direction of the monitor trolley 96
Monitor trolley park position 96
Park position of the monitors with height-adjustable
monitor column (optional) 97
3.3 Emergency Situations 98
3.3.1 Function of the Emergency Stop button 98
Overriding the brakes 99
3.3.2 Behavior in case of power failure 99
Restarting 99
3.3.3 Restarting the Cios Alpha 100
3.3.4 Restart via reset 100
Resetting 101
3.3.5 Procedure for cardiopulmonary resuscitation (CPR) 101

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3.1 Device Description

3.1.1 System overview

The Cios Alpha consists of a C-arm system and a monitor trolley.

(1) C-arm system with CMOS flat detector (20 cm x 20 cm or 30 cm x 30 cm depending

on the configuration) and dual-focus rotating anode X-ray tube with generator
(2) Monitor trolley with touch screen, mouse, USB port, two rotatable TFT displays, DVD
drive, and memory for 300,000 images

Standard equipment
The following equipment is included in the basic configuration of the Cios Alpha:

Monitor trolley • 2 TFT high-brightness color displays

• DVD recorder

• Uninterruptible power supply (UPS)

C-arm • 20x20 CMOS flat panel detector

• Single tank with 12 kW

• Dose measurement chamber for dose area product meter (DAP meter)

Control elements • Control panel on the monitor trolley

• Control unit on the C-arm system

• Standard footswitch

• Hand switch

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Options
The following options are available for the Cios Alpha:

Monitor trolley • Height-adjustable and foldable (Park position) monitors

• 2 TFT Premium high-brightness color displays (alternative to standard TFT high-

brightness color displays)

• DVI video splitter (Monitors A and B)

• Video manager

• Wireless network connection (WLAN)

• Sony UP-D898MD thermal printer

Economical, light-weight, compact printer for A6 b/w printing on thermal paper

• SONY UP-971AD, UP-991AD thermal printer

Economical, light-weight printer for A4 b/w printing on thermal paper (UP-971AD,
UP-991AD) and transparent film (UP-991AD)

• Audio package

C-arm • 30x30 CMOS flat panel detector

• Single tank with 25 kW or 25 kW ESU

• Active cooling (for 12 kW version)

• Motorization package (orbital/angular)

• Position memory

• Interface for injection pump triggering

• Integrated detector laser light localizer

• Single-tank laser light localizer

Control elements • Motorization package control module

• Remote control unit

• Additional holder for remote control unit

• Remote control unit cart

• Multifunctional footswitch (with extended functionality)

• Multifunctional footswitch, wireless (with extended functionality)

Applications • Vascular Software

• Vascular Software Premium

• Digital subtraction angiography (according to DIN 6868-150), with up to 7.5 P/s

(without ESU) and 30 P/s (with ESU)

• Additional operating mode Digital Cine Mode (DCM) with up to 30 P/s

• 2D measuring function (for measuring angles and distances)

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• Stenosis quantification

• Cios OpenApps*
*The Cios OpenApps is not commercially available in all countries. Their future
availability cannot be guaranteed.

• Target Pointer

• DICOM Worklist

• DICOM Send

• DICOM Print

• DICOM Query/Retrieve

• Radiation lock code

• HIPAA (Health Insurance Portability and Accountability Act)

Interfaces • DVI video splitter (Monitors A and B)

• Video manager

• Injector interface

• NaviLink 2D (integrated digital navigation interface for lossless transfer of 2D image

data to a navigation system)

Accessories • Grounding cable for potential equalization

• DHHS spacer

• Sterile covers for the detector, single tank, and C-arm

• Sterile cover for the remote control unit

• Non-sterile cover for (Standard/multifunctional) footswitch

• Clamp

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3.1.2 C-arm system

(1) C-arm
(2) Control unit
(3) Horizontal support arm
(4) Handles on both sides with a holder for the hand switch, as well as a steering
handle (center) for moving/transporting and braking the C-arm system
(5) Lifting column
(6) Cios Alpha Electronics unit
(7) Footswitch (standard)
(8) Flat detector with grid
(9) Handles for manual movement/positioning of the C-arm
(10) Single tank with X-ray tube unit and integrated collimator
The red dot on the cover marks the position of the focal spot.
(11) Wheels with cable deflectors

Flat detector with anti-scatter grid

Compared with the classic image intensifier, the flat detector has a much higher
dynamic range. This enables an expansion of the application range, for example, to soft
tissue imaging.

The anti-scatter grid attached to the flat detector further increases image quality.

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(1) Handle for manual movement/positioning of the C-arm

(2) Flat detector
(3) Removable anti-scatter grid
(4) Brake keypad on the detector housing
Optional button (1) on the brake keypad for switching the laser light localizers on and off.

Single tank

(1) Exit window for optional laser light localizer

(2) Integrated collimator system

Dose measuring chamber (DAP meter)

The DAP meter is integrated in the single tank of the Cios Alpha. The DAP meter
determines the dose area product (DAP) and air kerma values ( Page 267 Dose and
consistency test). The cumulative patient data are displayed on the monitor trolley
during the examination ( Page 142 Radiation information).

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Dose measuring chamber (DAP meter), integrated in the single tank

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3.1.3 Monitor trolley

(1) Radiation display

(2) Monitors can be rotated by 180°
(optional: folding monitors)
(3) Control panel
(4) Handles: for neat cable storage
(5) Drawer for storage of CDs/DVDs, Quick Guide, etc.
(6) DVD R/W drive
(7) Wheels with cable deflectors
(8) Monitor column
(optional: height adjustable)
(9) Storage for mouse, MP3 player;
Cios Alpha on/off switch, connections for USB, mouse
(10) Connection for WLAN, LAN, Reset key
(11) Shelf for printer
(12) UPS window (Charge state)
(13) Central locking brake

UPS display field

(1) UPS window

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The UPS display field on the front of the monitor trolley shows the charge state of the
batteries and the operating status.
(1) LED “Green”: Input voltage (line power operation)
(2) LED “Yellow”: Battery operation
(3) LED “Red”: Alarm, malfunction
(4) Bar display of utilization ratio
(5) Bar display of battery charge status

When the red LED is lit, the Cios Alpha is no longer protected against power outages
by the UPS. The power plug may not be pulled until the imaging system is shut down.
If this is the case, notify Siemens Healthineers Customer Service.

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3.1.4 Control elements

The following graphic is an overview of the Cios Alpha control elements. Some of the
control elements presented here are available as options.

(1) Control unit on the C-arm

(2) Hand switch
(3) Control panel on the monitor trolley
(4) Optional: Remote control unit with cable
(5) Standard footswitch
(optional: multifunctional footswitch, multifunctional footswitch wireless)

Use only your fingers to operate the touch screens. Do not use hard or sharp objects.

Control unit on the C-arm system

The control unit for performing your examinations is located on the C-arm system.

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(1) Power supply indicator (LED)

(2) Radiation indicator
(3) EMERGENCY STOP
(4) Vertical movement of the C-arm
(5) Releasing/locking the C-arm brakes
(6) Control panel
(7) Control module for the motorization package (optional)

The control panel on the C-arm control unit offers the same functions and shows the
same user interface as the control panel on the monitor trolley.

The control panel is not an imaging device as prescribed in DIN 6868-157. Any images
displayed are not suitable for diagnostic purposes.

Control panel on the monitor trolley

The monitor trolley control panel is used to operate applications for preparing (e.g.
entering patient data) and evaluating examinations. The control panel is integrated into
the cover plate of the monitor trolley.

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(1) Control panel on the monitor trolley

The control panel is not an imaging device as prescribed in DIN 6868-157. Any images
displayed are not suitable for diagnostic purposes.

There is also a mouse, which is used as usual to execute functions on the left monitor.

Hand switch

(1) Yellow button for radiation release

(2) Holder for hand switch
(3) Key for saving images

Footswitch
The footswitch pedals assignment can be configured.

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Configuration for foot pedal assignment

(1) Radiation release in preselected operating mode (standard setting)

Exception: Single image when fluoroscopy operating mode is preselected
(2) Radiation release for fluoroscopy (Standard setting)

In addition, the image saving function can be allocated to a pedal if desired. (Standard
footswitch only).

3.1.5 Operating modes

The following presents the operating modes of the Cios Alpha, their properties, and
assigned system settings.

Fluoroscopy
For Fluoroscopy operating mode, you can choose between several examination
sets with different characteristic curves for fluoroscopy to determine the radiation
parameters for fluoroscopy. Every application allows you to choose between different
optimized programs.

The pulse duration is generally between 5 and 14 milliseconds. According to the level of
noise reduction, many different fluoroscopic images can be integrated.

The standard setting of the Cios Alpha after startup is established in the configured
standard application, and in general is Fluoroscopy ( Page 248 Examination settings
(PEX Editor)).

System settings Exposure factors and system control units, including the way in which the automatic
setting is controlled:

• 1.4 k2 matrix (20 cm x 20 cm detector);

2.0 k2 matrix (30 cm x 30 cm detector);

• Frame rate usually 0.5 to 30 frames/s;

• Image integration (as a function of the k factor set), i.e., a number of k exposures are
integrated into one image by sliding averaging; the k factor can be selected between
k = 1 (“OFF” setting) and k = 16 (32 for LIH) and can be assigned to an examination set
and stored.

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Typical clinical procedure Fracture reposition of the distal upper extremity (e.g. distal forearm fracture) in the
plaster room of an emergency outpatient clinic where, under fluoroscopy, the fracture
elements are reduced by extension, fixed temporarily in the best possible position and
then fixed permanently by applying a plaster cast.

The Fluoroscopy operating mode is categorized as radioscopy (IEC 60601-1-3 3.69).

Single image
The Single image operating mode provides an electronic instant image of the patient on
the monitor. It is recommended for final exposures. The exposure time depends on the
pulse width set.

System settings Exposure factors and system control units, including the way in which the automatic
setting is controlled:

• 1.4 k2 matrix (20 cm x 20 cm detector);

2.0 k2 matrix (30 cm x 30 cm detector);

• X-ray pulse with a width of 5 ms up to a maximum of approx. 1400 ms.

Typical clinical procedure Final follow-up exposure of a fracture reposition of the distal upper extremity
(see above).

The Single Image operating mode is categorized as serial radiography (IEC

60601-2-54 201.3.209).

Digital Cine Mode (optional)

Due to its high frame rate (0.5–30 frames/s) and equally high performance, Digital Cine
Mode (DCM) can be used for the display of moving objects (e.g. heart).

The Digital Cine Mode operating mode is categorized as serial radiography (IEC
60601-2-54 201.3.209).

Subtraction/Roadmap (optional)
The Subtraction/Roadmap option allows you to perform a digital subtraction
angiography and simultaneously display the unsubtracted angiogram on the second
monitor. Subtraction technique allows hemodynamic display as well as display of the
maximum vascular filling and Roadmap. The Roadmapping features can also be used for
other procedures.

System settings Exposure factors and system control units, including the way in which the automatic
setting is controlled:

• 1.4 k2 matrix (20 cm x 20 cm detector);

2.0 k2 matrix (30 cm x 30 cm detector);

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• Acquisition rate is freely selectable, usually 4 to 15 frames/s;

• Image integration (as a function of the k factor set), i.e. a number of k exposures are
integrated into one image; the k factor can be set between k = 1 and k = 16 (32 for LIH)
by an authorized technician.

Typical clinical procedure • Display of an arterial vessel for localizing vascular stenoses with injection of a contrast
agent to enable the contrast-enhanced display of the vascular filling (subtraction of
the native image (mask) from the contrast-enhanced image).

• Alternative to native display, subsequent inversion of the displayed image allows you
to display a catheter introduced into the vessel path using the Roadmap function.

For information on performing an examination with Subtraction or Roadmap, refer to

( Page 153 Performing special examinations).

The Roadmap operating mode is categorized as radioscopy (IEC 60601-1-3

3.69). The Subtraction operating mode is categorized as serial radiography (IEC
60601-2-54 201.3.209).

3.1.6 Description of image processing

The system's overall image processing is known as the “imaging chain”. The imaging
chain is divided into hardware and software modules. It includes image sources (e.g., flat
panel detectors), modules for preprocessing and postprocessing images, and image data
display (e.g., monitor).

The imaging chain is also responsible for setting the correct parameters for the various
components. Raw image data is transfered from the flat panel detector via various
preprocessing steps to the imaging system PC. On the PC, the image data is then analyzed
and processed in real time, and an initial adjustment of the brightness and contrast is
performed. Finally, the image data is transferred to the imaging system software where
it is stored.

At the same time, the image data is processed for optimum medical evaluation for the
application in question (including local filtering, subtraction, brightness and contrast
processing, geometric operations, peak opacification) and displayed on one or more
monitors. Previewing on touch displays is carried out in the same way.

During a DICOM export the image data is not transferred as raw data but with all
related processing steps (including any manual image adjustments such as windowing
or annotations). From there it is sent to an archive (DICOM) along with the patient
data. The original state cannot be restored. (Therefore do not use these images for the
primary diagnosis!)

3.1.7 Image display

The imaging system uses two monitors for image display.

• The left monitor is used to display live images as well as preoperative and
postoperative images.

• The right monitor is used to display the reference images.

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Reference images may be:

• preoperative images, incl. images of other modalities (e.g. CT, MR)

• images of current examinations

• images from previous examinations

(1) Control area with function displays

(2) Image area

3.2 System Operation

3.2.1 Start-up

Ensure that plugs and connectors are clean and dry.

Do not use damaged cables.

Connecting the C-arm system with the monitor trolley

The C-arm system is connected to the monitor trolley with a cable.

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CAUTION

Tripping over cable.

Risk of falling.

◆ When routing cables, make sure they run on the floor properly and
without loops.

1 Plug the central plug into the socket on the left side of the C-arm system, when
viewed from the C-arm. The switch must always be in the vertical position.

The monitor trolley may only be connected to the corresponding C-arm system. If
the monitor trolley is connected to the wrong C-arm system, an error message is
displayed indicating that the C-arm and monitor trolley are not a suitable pairing.
Upon acknowledging the message, the text "Incorrect C-arm" indicating the status is
displayed at the lower left of the imaging system monitor.

Contact Siemens Healthineers Customer Service to have the monitor trolley and the
C-arm system configured as one system.

2 Turn the central plug switch to the right until it audibly clicks into place.
The monitor trolley is connected to the C-arm system.

Connecting the footswitch

For the release of radiation with the footswitch, it must be connected to the C-
arm system.

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◆ Plug the footswitch cable into the socket labeled with the footswitch symbol on the
front of the C-arm system.

Establishing the connection for potential equalization

The Cios Alpha can be connected to an external potential equalization terminal via the
potential equalization terminal on the C-arm system. This will ensure that the Cios Alpha
has the same electrical potential as other units connected to the same external potential
equalization terminal.

Potential equalization is required when performing cardiac examinations or

examinations of the open skull.

◆ Clamp the potential equalization cable to the terminal indicated by the symbol
on the C-arm system front connection panel (arrow) and to an external potential
equalization terminal in the vicinity of the patient.

Thus, potential equalization is established.

Establish the power line connection

The Cios Alpha operates using a line power connection cable from the monitor trolley to
a properly grounded socket.

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

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WARNING

Cable damage.

Risk of electrical shock!

◆ Check the power cable. Do not use the device if the power cable is damaged.

1 Plug the monitor trolley power plug into the appropriate socket.

The line power connection is established.

2 Position the unit so that it is easy to disconnect from the line power.

Switching on the Cios Alpha

◆ Press the right ON button on the monitor trolley.

The button that can be used to make a change is always illuminated. Thus, when the
system is shut off, the ON button is illuminated.

Functions during system start-up

The Cios Alpha is switched on.

The system automatically runs a self-test.

On the control panel, all LEDs light for approx. 2 seconds as a function test and then
switch off automatically.

Check whether all LEDs light correctly. If not, notify Siemens Healthineers Customer
Service as there could be a malfunction.

An audible signal sounds while the system starts up.

If an audible signal does not sound, notify Siemens Healthineers Customer Service;
there is a possibility that audible signals will not play back correctly.

An automatic self-test is performed for the C-arm control unit buttons.

Do not press any keys (such as the lift key) during booting; otherwise, an error message
will be displayed indicating that a key was pressed during booting, and therefore the
self-test of the keys did not function.

If error messages are displayed during the self-test, a new self-test is performed
automatically. The self-test can be performed up to four times.

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A failed self-test is indicated on the affected control panel by continuous flashing of all
LED fields. Use of the buttons is not possible in this state; the affected control panel is
then shut down automatically. In this case, Siemens Healthineers Customer Service must
be notified.

Display of software version During start-up, a start-up screen is displayed on the left monitor stating the current
software version of your system.

Radiation stand-by

On the left monitor, radiation stand-by is indicated by a symbol in the status bar (lower
left) after a patient has been registered. On the control panel, radiation stand-by is
indicated by a green horizontal bar in the exposure parameters area (top left).
This icon appears on the monitor if radiation release is blocked. On the control panel,
the horizontal bar is grey. You need to enter the password to unlock the radiation release
( Page 111 Unlocking/locking radiation release).

Radiation cannot be released if the monitor trolley is operated separately. On the control
panel, the horizontal bar is white.

Essentially, the system is not ready for radiation unless a patient is registered.

If the C-arm system is connected to a monitor trolley that is already switched on, it
normally becomes available after 120 s. It is then in the same operating state as it was
prior to being disconnected from the monitor trolley.

Flat detector calibration If a message is displayed on the monitor indicating that flat detector calibration is due:
message

1 Perform detector calibration.

2 Confirm it to continue start up.

All images acquired with an uncalibrated system are tagged "without

valid calibration".

Presettings The following functions are set when the Cios Alpha is started:

• Operating mode: the preset operating mode in the application configured as

Standard ( Page 248 Examination settings (PEX Editor))

• Image mirroring: switched off if it is not switched on in the application configured as

Standard ( Page 248 Examination settings (PEX Editor))

• Number of images (fluoro): the default value in the application configured as

Standard ( Page 248 Examination settings (PEX Editor))

• Automatic dose rate control (ADR): Activated

• Zoom level: 0, if it is not switched on in the application configured as Standard

( Page 255 Editing applications)

• Collimators: Full format

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3.2.2 Move C-arm

The horizontal movement, swivel movement, angulation and orbital movement of the
C-arm are performed manually. Use the handles on the C-arm or the flat detector.

Additionally, the C-arm can be adjusted in height by motor control.

Motorized angulation and orbital movements are possible only with the motorization
package (optional).

CAUTION

Manual or motorized movements.

Risk of crushing and collision for persons and objects in the vicinity of
moving parts.
◆ During manual and motorized movements of the device, make sure you take
into account any persons or objects in the way of movement, and control the
movement to avoid collisions.
◆ Make sure that everyone is outside the hazardous zone.

CAUTION

Unintentional activation of movement.

Risk of injury and crushing!
◆ Angulating the C-arm > 90° may cause the cable to collide with the operating
unit on the horizontal support arm and accidentally operate movements.

CAUTION

Activation of system movements without visual contact.

Risk of crushing!
◆ Use the system only if the patient and other persons can be observed
during movements.

CAUTION

C-arm rotation.

Risk of crushing!
◆ Pay particular attention to crushing risks between moving system parts and the
corresponding guide openings.

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CAUTION

Movement due to unintended actuation of operating elements.

Risk of collision, risk of injury to the patient or operator, risk of damage to the
device parts.

◆ Press the closest EMERGENCY STOP button if device movements do not stop.

Please note that the scale on the C-arm is intended for orientation only, not
for measurement.

Operating the brakes

The Cios Alpha is equipped with electromagnetic brakes that you can control with
the C-arm system control unit, the remote control unit, and the brake keypad on the
flat detector.

CAUTION

Brake failure.

Risk of crushing!
◆ Before beginning the examination, perform the daily function and safety checks.

The buttons for releasing and locking the brakes for different directions of movement are
marked with different colors. A graduated scale in the same colors for the corresponding
directions of movement is located on the housing.

Releasing the brake Before moving the C-arm, the brake for the relevant direction of movement must
be released.

◆ Press the button for the brake for the desired direction of movement.

The “brake released” indicator (open lock) lights up orange. The corresponding brake
is released.

You can move the C-arm.

Engaging the brake ◆ Press the button for the brake again.
The “brake released” indicator goes out. The corresponding brake is locked.

You can no longer move the C-arm in this direction.

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Engage the corresponding electromagnetic brakes after moving the C-arm.

Lifting and lowering the C-arm

You can lift and lower the C-arm by motor control using the arrow buttons on the C-arm
system control unit.

The lifting column can be lowered from position 1 (highest level) to intermediate
position 2, down to position 3 (lowest level).

(1) Position 1 = highest level

(2) Position 2 = intermediate position
(3) Position 3 = lowest level

Lifting the C-arm

◆ Press the Up button on the C-arm system control unit.

The lifting column moves upwards.

Lowering the C-arm The lifting column can be lowered to position 3.

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1 Press the Down button on the C-arm system control unit.

The lifting column then moves to the intermediate position (2) and automatically
stops there.
2 Press the Down button on the C-arm system control unit again.

The lifting column is lowered further.

An audible signal sounds.

Make sure there is nothing in the hazard zone (under the C-arm or travel frame) when
lowering the C-arm; crushing hazard!

Lifting movement failure If the lifting column cannot be moved the EMERGENCY STOP button is pressed and must
be unlocked.

1 Turn the knob clockwise until it pops back out.

2 If the lifting column can still no longer be moved in any direction, then please contact
Siemens Healthineers Customer Service.

Moving the C-arm horizontally

You can move the support arm horizontally by up to 20 cm.

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1 Press the button marked in green for the horizontal movement brake.
The brake is released.

The “brake released” indicator lights up orange.

2 Move the support arm to the desired position while observing the green scale.

3 Press the button for the brake again.

The brake is locked.

The “brake released” indicator goes out.

Swivelling the C-arm

You can move the C-arm in the horizontal plane ± 12° about the lifting column.

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1 Press the button marked in orange for the horizontal swivel brake.

The brake is released.

The “brake released” indicator lights up orange.

2 Swivel the C-arm to the required position.

3 Press the button for the brake again.

The brake is locked.

The “brake released” indicator goes out.

Angulating the C-arm

You can rotate the C-arm in the vertical plane ± 225° about the horizontal support arm.

(1) Electromagnetic brakes

(2) Control panel
(3) Control module for the motorization package (optional)

1 Press the button marked in yellow for the angulation (1) brake.

The brake is released.

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The “brake released” indicator lights up orange.

2 Rotate the C-arm to the required angulated position while observing the yellow scale
on the support arm joint.
3 Press the button for the brake again.

The brake is locked.

The “brake released” indicator goes out.

Using the optional control module for the motorization package (3), these C-arm
movements can be motorized. Refer to the description in ( Page 350 Control module for
the motorization package).

Orbital movement of the C-arm

Starting from the basic position (0°), you can swivel the C-arm by up to +96.5° or up to
-51.5° (148° in total).

Do not move the C-arm if the orbital brake is activated. In case of emergency (patient
recovery during power failure), the C-arm can be moved in the direction desired without
releasing the brakes when enough strength is applied.

(1) Electromagnetic brakes

(2) Control panel
(3) Control module for the motorization package (optional)

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1 Press the button marked in blue for the orbital movement (1) brake.

The brake is released.

The “brake released” indicator lights up orange.

2 Swivel the C-arm to the required orbital position while observing the blue scale
( Page 79 Orbital scale of the C-arm).

3 Press the button for the brake again.

The brake is locked.

The “brake released” indicator goes out.

Using the optional control module for the motorization package (3), these C-arm
movements can be motorized. Refer to the description in ( Page 350 Control module for
the motorization package).

Orbital scale of the C-arm When reading the orbital angle always use the blue scale on the right-hand side of the
C-arm (when viewing from the C-arm control unit towards the C-arm opening). This
applys to both, the upper and the lower detector positions. An arrow at the horizontal
support arm indicates which scale is valid.

Right-hand side of the C-arm, flat detector in the upper position (left) and lower position (right)

3.2.3 Control panel

The control panels on the C-arm control unit, monitor trolley, and (optional) remote
control unit are identical in terms of function and display.

Press the corresponding symbol button to operate the function.

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(1) Displays and operating elements for the exposure parameters

(2) Task cards with operating elements for the current work step
(3) Close pat. (close patient) button
(4) Button to manually select keyboard mode

Exposure parameters
The left section of the control panel contains the operating and display elements for
image acquisition. This area remains the same regardless of the task card selected.

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(1) Radiation stand-by indicator

Green: ready, white: not ready, e.g., C-arm system not connected or patient not
registered, grayed: Radiation release blocked (password entry required)
(2) Display elements and position memory
Current C-arm angles (for motorized operation and position memory), cumulative
dose and radiation time, kV, mAs/mA, indication of grid status
(3) Exposure preparation
Collimator setting, laser light localizer, reset warning signal (radiation time)
(4) Operating mode selection
Fluoroscopy (Fluoro), Single image, and optional Subtraction (Sub), Roadmap
(Road), Digital Cine Mode (DCM)
(5) Setting of radiation parameters
Dose, Metal correction, Automatic dose control (ADR), zoom, noise filtering and
motion detection, pulse frequency

Task cards
The task cards provide you access to all required operating elements in the current
work step.

In the PROCESSING work step you are provided with operating elements for
image postprocessing.

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(1) Basic operating elements for image display

(2) Operating elements for special applications (optional)
(3) Operating elements for image postprocessing and -evaluation
(4) Area for displaying submenus ( Page 83 Submenus)
(5) Image and information area

Changing task cards

◆ Press the tab of the required task card.

Control elements
You perform individual function and set the required parameters using the task card
operating elements.

When you press a button and a dashed line appears, this means the requested function
is being processed by the system. No additional operating steps are possible during
this time for safety reasons.

Function value display: For some functions, the current set value is displayed in the
operating element (example: Pulse rate 15 p/s).

Function inactive: Many functions can only be executed when specific conditions are
met (for example, Hold reference only when the image display is on the right monitor).
Functions that currently cannot be executed appear as inactive.

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Performing the function

◆ Press the button for the required function.

For some functions the button can be pressed and held to continue performing the
function (such as moving the collimator).

Activating/deactivating For functions that can be switched on or off, the button with the light background
functions indicates the active state.

1 Press the button in deactivated state to switch on the function.

2 Press the button in activated state to switch off the function.

Submenus
For functions requiring further input or additional settings, corresponding operating
elements are available in a submenu.

Opening the submenu

1 Press the button for the required function.

The function is activated.

A submenu with function-specific operating elements is shown in the upper section

of the task card.

2 Change the settings using the operating elements shown.

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Close the submenu

◆ Press the Close button.

– or –

Press the button for the required function again.

Select a different submenu.

Keyboard mode
Keyboard mode is used to enter text and numbers.

(1) Text field

(2) Keyboard
(3) Symbol button bar for opening functions (visible only if appropriate for the current
work step)

Opening keyboard mode The system switches automatically to keyboard mode when functions requiring text
input are opened (such as for patient registration). Keyboard mode can be opened
manually when necessary (e.g., for service purposes).

◆ Press this button on the control panel (lower right).

A virtual keyboard appears on the control panel instead of the task cards.

Entering text ◆ Press the corresponding character buttons like a computer keyboard.

The entered characters are shown in the input screen on the monitor and in the white
text field of the virtual keyboard.

For upper case letters, press the Shift button and then the corresponding character.

Entering special characters You have several options for entering special characters.

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◆ Press one of the following key combinations:

• The Shift button and the desired special characters

• Alt + Ctrl.

• Alt + Ctrl + Shift

When using a USB keyboard, ensure that the layout matches the keyboard layout of the
user interface on the monitor trolley; otherwise incorrect entries can occur.

Ending keyboard mode Keyboard mode ends automatically when the corresponding input screen on the monitor
is closed. Depending on the function that is open, this can be done with the Enter button
(such as comment text) or by opening the next work step (such as examination after
patient registration).

◆ To terminate keyboard mode manually, press the Close button.

The task card previously shown is displayed again.

Enlarged preview image (blow-up)

You can always enlarge (blow up) the displayed image using the control panel.

1 Tap the image area.

The displayed image is enlarged across the entire task card range.

Menus to interactively change the image display and radiation parameters appear on
the right side.

(1) Blow-up area

(2) Menus for image display and radiation parameter settings

2 Open the required menu on the right side of the control panel.

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3 Adapt the image display and the radiation parameters with your finger tips in the
blow-up area.

See ( Page 86 Changing settings in enlarged preview)

4 Press the “Close” button to reset the control panels to normal display.

Changing settings in enlarged preview

In blow-up mode of the control panels, you can make the following modifications after
opening the respective menus:

• Rotating/flipping an image.

• Changing the brightness/contrast of an image.

• Zooming/panning an image.

• Starting/pausing cine replay with the Play/Pause toggle button.

• Adapting the collimation.

• Adjusting dose control and / or contrast enhancement to an individual region

of interest.

3.2.4 Operating the hand switch

The hand switch is used to remotely control radiation release and image storage.
The hand switch can be inserted into the holder provided on the C-arm system.

(1) Radiation release key

(2) Image storage key

Radiation release
The hand switch is used to release radiation in the preselected operating mode.

◆ Press the yellow radiation release key on the hand switch and hold it down while
radiation is released.

The current radiation parameters are shown on the control units.

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The currently generated image is displayed on the left monitor unless the Hold
reference function is active.

Image storage
During radiation

◆ Press this key on the hand switch.

The image currently generated and displayed is saved.

After radiation

◆ Press this key on the hand switch.

Holding the key for < 2 seconds: Saves the image last recorded (LIH).

Holding the key for > 2 seconds: Saves the scene last recorded (LSH).

The images are stored in the local database. They are transferred from the left monitor
to the right monitor unless the Hold reference function is active.

Storage
When not in use, the hand switch can be kept in one of the holders on either side of the
C-arm system.

3.2.5 Operating the footswitch

The footswitch is used, for example, if both hands need to be free during the exposure.

The footswitch is also suitable for applications where fluids may land on the floor.

For operation of the multifunctional footswitch (optional) see

( Page 339 Multifunctional footswitch).

Radiation release
In the default setting, the pedals of the footswitch are allocated as follows:

• The right pedal is always used to activate Fluoroscopy (Fluoro).

• The left pedal is used to activate the preselected operating mode.

Exception: If the Fluoroscopy (Fluoro) operating mode is preselected, the left pedal
is allocated the Single image operating mode.

The left/right functionality of the two pedals can be reversed by Siemens Healthineers
Customer Service upon request.

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Pedal allocation:

The current pedal allocation is shown on the monitor trolley left screen.

If the footswitch is defective or not connected, the symbol for the hand switch is
displayed instead.

Releasing radiation

◆ Keep the left or right foot pedal pressed during radiation release.

The current radiation parameters are shown on the control units.

Image storage
One of the pedals can be configured with the "Save" function by Siemens Healthineers
Customer Service. In this case, in the default setting the pedals of the footswitch are
allocated as follows:

• The right pedal is used to activate the preselected operating mode.

• The left pedal is used to activate image storage.

Saving during radiation

◆ Press the "Save" pedal on the footswitch.

The image currently generated and displayed is saved in the local database.

Saving after radiation

◆ Press the "Save" pedal on the footswitch.

Holding the pedal for < 2 seconds: Saves the image last recorded (LIH).

Holding the pedal for > 2 seconds: Saves the scene last recorded (LSH).

The images are stored in the local database. They are transferred from the left monitor
to the right monitor unless the Hold reference function is active.

3.2.6 Switching off

Before disconnecting the Cios Alpha from line power, you must shut it down. During the
shutdown procedure the imaging system is shut down before the system is switched off.

The shutdown procedure for the imaging system is complete when the stand-by
indicator in the left monitor goes out.

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CAUTION

Loss of image data.

Risk of unnecessary radiation exposure!

◆ Do not shut down the system while radiation is being released.

If you still need the monitor trolley (for postprocessing), you can disconnect the C-arm
system while switched on. In this case, only the C-arm system is shut down.

Switching off the system completely

Ending active processes 1 Close the current patient with the corresponding button on the control panel.

2 If you have just started a print job, wait until the job is completed.

3 Make sure data were not written to CD/DVD.

If necessary, wait for CD/DVD write processes to be completed.

4 If there is a disk in the CD/DVD, take it out of the drive.

Open network export jobs are retained during shutdown and are continued when the
system is switched back on. Storage jobs for removable devices as well as print jobs are
stopped and deleted.

Switching off

◆ Press the OFF button on the monitor trolley.

The C-arm system is immediately switched off.

The imaging system switches off after the computer is shut down.

The button that can be used to make a change is always illuminated. Thus, when the
system is switched on, the OFF button is illuminated.

If Auto delete is enabled, the following message will be displayed before the computer
is shut down: “Autodeletion of studies scheduled for today. Do you want to proceed”.
Confirm this message to continue the shut-down procedure.

For information on activating and deactivating automatic deletion of images see

( Page 246 Deleting images automatically).

Switching off the C-arm system only

◆ Turn the central plug lever on the C-arm system to the left to unlock it. Unplug
the connector.

The C-arm system is immediately switched off.

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As long as a C-arm system is not connected, the acquisition functions on the imaging
system are not available.

Disconnecting Cios Alpha from line power

Please note that after finishing an examination, the Cios Alpha must be shut down
properly before it is disconnected from the power supply.
1 Switch off the Cios Alpha and wait for it to shut down.

2 Disconnect the monitor trolley power plug from the power outlet.

When the power plug is pulled, the UPS switches to battery mode (yellow
LED illuminates).

Pull on the plug, not on the cable!

Releasing the 1 Turn the central plug lever on the C-arm system to the left to unlock it. Unplug
connection cable the connector.

2 If attached, disconnect the connection to the potential equalization terminal from

the C-arm system.

Removing the remote ◆ See ( Page 347 Removing the remote control unit and holder).
control unit

Rolling up the footswitch The footswitch is placed in the holder provided for storage and during transport.
cable

◆ Roll up the footswitch cable (1) onto the cleat provided and place the footswitch into
its holder (2).

When attaching the footswitch, please be careful not to kink the cable.

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Reactivating the system

If the imaging system cannot be shut down properly after pressing the OFF button or if
it no longer reacts to input, you must reactivate the Cios Alpha system as follows:

1 Press the RESET button on the right side of the monitor trolley.

All running processes are terminated and the Cios Alpha is shut down.

2 Switch the Cios Alpha on again and let it boot up completely.

Now you can either continue using the Cios Alpha or shut it down.

If the Cios Alpha is not fully operational despite the reset, please notify Siemens
Healthineers Customer Service.

3.2.7 Transporting the C-arm system

The C-arm system is equipped with 4 wheels for easy steering in any direction. The C-arm
system can be locked in place with the steering/brake lever.

Preparing the C-arm system

Prior to transport, the C-arm system must be set to the transport position.

1 Release all brakes of the C-arm.

2 Set the C-arm to the transport position shown in the drawing.

Angulation 0°/Orbital position 0°.

3 Move the lifting column to its lowest position.

4 Move the horizontal support arm all the way back.

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Drive operation and steering of the C-arm system

With the steering lever, you operate the breaks of the C-arm wheels and steer the C-arm
in the required direction.

The steering lever can be locked into 3 different positions. One is for movement straight
ahead, the others for transverse travel to the right or left.

CAUTION

Weight of the device.

Risk of crushing!

◆ Fast braking can be impacted by the weight of the device. Pay attention to your
speed as well as the floor covering, slope, and uneven areas.

1 Press the release button and pull the lever up (indicator = green).

Drive operation for the C-arm system is now possible.

2 Turn the steering lever in the required direction.

3 Move the C-arm system by hand.

You have the following options for steering the C-arm system:

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• Motion straight ahead / pivoting in place

The brake is released, the steering lever is pointing straight up.

The C-arm system can now be driven straight ahead or pivoted in place.

• Diagonal motion

The brake is released, the steering lever is angled to the left or to the right.
The C-arm system can now be driven diagonally.

• Straight left or straight right motion

The brake is released, the steering lever is pointing straight to the left or the right.

The C-arm system can now be driven straight to the left or straight to the right.

Avoid transporting the C-arm system on inclined surfaces > 5° or it may slip or tip over.

When transporting the C-arm system make sure there are no obstructions on the floor.

Braking the C-arm system

To securely brake the C-arm system, particularly on tilted or uneven planes and surfaces,
proceed as follows:

◆ Keep the unlocking button pressed and lift the steering lever.
The red indicator appears.

The C-arm system brakes are now locked. However, even with the brake applied,
C-arm movements are still possible.

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C-arm system park position

CAUTION

Insufficient braking force.

Risk of crushing!

◆ When parking the C-arm system on an inclined surface, lock the brakes on the
C-arm system and turn the wheels perpendicular to the slope.

1 Lock the brakes on the C-arm system.

The red indicator appears (brakes locked).

2 Set the steering lever to lock position for transverse travel to the right or left, so that
the wheels are braked in transverse position.

3.2.8 Transporting the monitor trolley

Preparing the monitor trolley

Prior to transport, the rolled-up power cable and the connection cable for the C-arm
system should be placed on the handles of the monitor trolley.

WARNING

Increased tipping effect.

Risk of crushing!
◆ Only products/components approved by Siemens Healthineers may be installed.

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◆ Hang the rolled-up cables on the handles of the monitor trolley.

Avoid transporting the monitor trolley on inclined surfaces > 5° or it may slip or tip over.

Moving the monitor trolley

◆ Release the central brake on the front of the monitor trolley (see arrow) to start
moving it.

When the monitor trolley is moved, care must be taken that it does not collide with,
for example, catheters or anesthesia tubes.

Locking the monitor trolley

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◆ To lock the monitor trolley, push the center brake down with your foot until it
stops/engages.

CAUTION

Brake failure.

Risk of crushing!

◆ Before beginning the examination, perform the daily function and

safety checks.

Setting the direction of the monitor trolley

◆ Push the center brake upwards with your foot until it stops/engages.

This locks the front right wheel into a fixed position when moving the monitor trolley,
and thereby sets the direction of movement.

The monitor trolley then can be pushed in the direction of the set front wheel.

Monitor trolley park position

CAUTION

Insufficient braking force.

Risk of crushing!
◆ When parking the monitor trolley on an inclined surface, face the front toward
the incline and lock the brakes.
◆ Make sure the monitor trolley is not parked on a wet floor or other places where
the adhesion of the wheels is greatly reduced.

On inclined surfaces with an angle of > 5°:

1 Make sure that the brakes are locked.

2 Make sure that the front of the monitor trolley faces forward in the direction of
the incline.

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Avoid disconnecting the monitor trolley from power supply for more than one week.
Otherwise, the UPS battery may not be fully charged.

Park position of the monitors with height-adjustable monitor

column (optional)
The monitor trolley holds two rotatable monitors. Using the corresponding option, these
can be height-adjusted and folded up for transport.

(1) Height-adjustable monitors

(2) Toggle switch for height-adjustment of the monitors

The height of the monitors can be adjusted with the toggle switch.

1 Press the arrow symbol for Down on the toggle switch.

Motors move the monitors down; they can only be lowered to a specific end position.

CAUTION

Motorized movements.
Risk of crushing!

◆ Do not stand in the travel range of the monitor or place objects on the
trolley housing.

2 Prior to transport fold the monitors together to prevent colliding with obstructions.

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CAUTION

Folding the monitors.

Risk of crushing!

◆ Be careful when folding in the monitors - your hands could get caught.

3.3 Emergency Situations

Keep a replacement unit ready for critical applications in an emergency. Refer to

( Page 25 System failure).

3.3.1 Function of the Emergency Stop button

A red EMERGENCY STOP button is located on the C-arm system control unit and the
(optional) remote control unit.

The EMERGENCY STOP button stops the following processes immediately in a

hazardous situation:

• motorized C-arm movements

• released electromagnetic brakes (will be locked)

• active radiation

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When the EMERGENCY STOP button is activated (pressed), a red lock symbol flashes
on the active emergency stop button. The lock symbol lights constantly on the other
emergency stop components as long as the emergency stop button is active in at least
one location.

If the EMERGENCY STOP button has been activated (pressed), radiation can still be
released manually and the brakes can be actuated manually. Motorized movements
are not possible, however.

◆ Unlock the EMERGENCY STOP button by turning it clockwise only when the
hazardous situation has been eliminated.

Overriding the brakes

In case of emergency (patient recovery during power failure), the C-arm can be moved
in the direction desired without releasing the brakes when enough strength is applied.

3.3.2 Behavior in case of power failure

In the case of a power failure, the unit is switched off. In order to prevent data/image
loss, an uninterruptible power supply (UPS) which carries out a controlled shutdown of
the imaging system is installed in the monitor trolley. The images of the last complete
examination are saved if the auto save function is switched on (Auto save must be on
for interventional applications).

The following are not saved:

• Current, not completed examination in the event of an unexpected shutdown or

power outage

• Collimator position

• Set dose

• Image orientation

• Position memory

• Zoom

If there is one, a hospital emergency power supply cuts in if the line power supply fails.
However, this usually occurs with interruption and can take some time.

The system can be restarted as soon as the mains power supply is available or the
emergency power unit is functioning.

Restarting
1 Press the ON button on the monitor trolley to restart the system.

2 Wait until the unit has fully rebooted.

3 Pay attention to error messages.

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When the power-up process has been completed (after approx. 2 minutes), the Cios
Alpha is fully operational again.
4 Reselect the last patient in order to continue his or her treatment.

5 Perform the procedure, dose and collimator settings required in order to continue
the application.

The positioning of the C-arm remains intact when the system is switched off.
Nevertheless, please check the current position and correct it if necessary.

3.3.3 Restarting the Cios Alpha

The Cios Alpha must be restarted following certain error messages.

The following settings are reset to their default values by a restart:

• Collimator position

• Set dose

• Image orientation

• Position memory

• Zoom
1 Switch the system off by pressing the OFF button on the monitor trolley.

2 Wait until the computer has shut down.

3 Press the ON button on the monitor trolley to restart the unit.

4 Pay attention to the error messages displayed.

5 Reselect the last patient in order to continue his or her treatment.

6 Perform the procedure, dose and collimator settings required in order to continue
the application.

The positioning of the C-arm remains intact when the system is switched off.
Nevertheless, please check the current position and correct it if necessary.

CAUTION

Imaging system is frozen or restart is not possible.

Risk of delay in the clinical procedure!

◆ Restart the system as presented in the following reset procedure.

3.3.4 Restart via reset

If the computer fails to shut down or no longer reacts to inputs, a system reset may
be necessary.

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The following information will be lost following a reset:

• Collimator position

• Set dose

• Image orientation

• Position memory

• Zoom

Resetting

1 Use a pin or a pointed object to actuate the reset button on the monitor trolley (the
system will not automatically boot up afterwards).

2 After the system switches off, press the ON button to switch the unit on.
Wait until the system has rebooted.

3 Reselect the last patient in order to continue his or her treatment.

4 Perform the procedure, dose and collimator settings required in order to continue
the application.

The positioning of the C-arm remains intact when the system is switched off.
Nevertheless, please check the current position and correct it if necessary.

3.3.5 Procedure for cardiopulmonary resuscitation (CPR)

If cardiopulmonary resuscitation (CPR) becomes necessary, the Cios Alpha must be
removed from the OR table to ensure free access to the patient.

1 Move the C-arm into a position where it can be removed from the table without
causing a collision.
2 Release the brakes and move the C-arm to the required position either via motor drive
or manually. Reapply the brake to prevent unwanted movements of the C-arm.
3 In the case of a power failure, the C-arm can be moved by applying excess pressure
to override the brakes.
4 If necessary, remove the remote control unit from the patient table and fasten it to
the monitor trolley.
5 Then release the brake lever and move the Cios Alpha out of the treatment area.

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6 At the same time, watch out for the cables leading to the monitor trolley, the remote
control unit and the footswitch.
7 Release the brake of the monitor trolley, if necessary, and remove it from the
treatment area.

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4 Examination
4.1 Safety information 106
4.1.1 Prior to the examination 106
Examination settings 106
Audible warnings 106
Software failure 106
Storage capacity 106
Reference images from previous examinations 107
4.1.2 During the examination 107
Patient position 107
Image orientation 107
Data conformity 107
Detector temperature 108
4.2 Preparing the system 108
4.2.1 Removing/inserting the anti-scatter grid 108
Removing the anti-scatter grid 109
Inserting the anti-scatter grid 109
4.2.2 Protection against contamination and the penetration of fluids 110
4.2.3 Positioning the C-arm 110
Using the laser light localizer 110
Operating the laser light localizer at the C-arm (optional) 110
Aligning the C-arm 111
4.2.4 Unlocking/locking radiation release 111
Unlocking radiation release 111
Locking radiation release 112
4.2.5 Selecting the application 112
Setting the application and application group 113
4.3 Patient registration 113
4.3.1 Emergency registration 114
Emergency registration on the control panel 114
Emergency registration on the monitor 115
Emergency registration with the hand switch or footswitch 115
Provisional patient data 116
4.3.2 Registering a new patient 116
Opening patient registration 116
Data Entry Dialog window 116
Entering data 118
Completing registration 119
4.3.3 Registering previous patients 119
Opening the Patient list 120
Checking/correcting patient data 120
Completing registration 121
Resuming a commenced study 121
4.3.4 Registering patients from the worklist 121
Updating the worklist 122
Opening the worklist 123
Checking/correcting patient data 123
Completing registration 124
Deleting a patient entry 124

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4.4 Defining the examination settings 124

4.4.1 Changing the fluoroscopy parameters 125
Selecting the operating mode 125
Setting collimators 127
Adapting the collimation in enlarged preview 128
Selecting the dose rate level 129
Switching on metal correction 130
Selecting the motion/noise filter 130
Selecting the input format (Detector zoom/magnification) 131
Setting the pulse rate 132
Setting the X-ray parameters manually 132
Adjusting dose control and / or contrast enhancement
to an individual region of interest 134
4.4.2 Setting the image parameters 135
Selecting the image orientation 135
Standard image orientation 136
Rotating/flipping images 136
Rotating/flipping images in enlarged preview 137
4.5 Acquiring images 138
4.5.1 Releasing radiation 138
Dose regulation indicator 139
Displaying fluoroscopy images 140
Confirming a warning signal 141
Temperature monitoring 141
Radiation information 142
4.5.2 Saving and displaying images 143
Storing images (during radiation) 143
Storing images (after radiation) 143
Saving and reviewing a scene 144
Reviewing a scene in enlarged preview 145
Reviewing a scene (Digital Cine Mode) 145
Changing the image display 145
Recording video 146
4.5.3 Using reference images 146
Transferring Images 146
Scrolling through images 147
Holding the reference image 147
Loading images from an external video source 148
4.5.4 Using “Cios OpenApps” (optional) 148
Selecting an application 149
Transferring images to the application 149
Terminating the application 151
4.6 Ending the examination 151
4.6.1 Closing the patient 152
4.6.2 Examining the next patient 152
Another patient registered 152
4.7 Performing special examinations 153
4.7.1 Digital subtraction angiography (Sub) 153
Progression 154
Performing subtraction angiography 154
4.7.2 Roadmap (Road) 155
Fill image available 155
Generating a new fill image 155
Using the fill image from subtraction angiography 156

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Manually selecting the fill image 156

Positioning the catheter (phase C) 157
4.7.3 Using graphics overlays 158
Live graph overlay menu 158
Drawing lines 158
Deleting points 159
Postprocessing lines 159
Deleting everything 159
4.7.4 Using the Target Pointer (optional) 159
4.7.5 Pediatric use 160

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4.1 Safety information

4.1.1 Prior to the examination

Examination settings
Before starting surgery, please make sure that all the set parameters as well as
examination settings in all operation modes are correct.

Audible warnings
Audible warnings over the loudspeakers indicate possible hazards, such as crushing
hazards, longer radiation release or high dose rate.

CAUTION

Audible warning for safety distance not functional.

Risk of crushing!
◆ Check for proper loudspeaker function before beginning the examination. Note
when booting the system whether an audible signal is heard.

Software failure

CAUTION

Software crash.
Working with the imaging system is no longer possible.

◆ Restart the system.

Storage capacity
The hard disc fill level is displayed in the status bar of the left monitor. A warning signal
is displayed before the final capacity of the hard disk is reached.

This icon, for instance, indicates that about 25 percent of the disk space has been used.

This icon, for instance, indicates that the available disk space has reached a critical level.

Please make sure that there is sufficient storage capacity before you start the
examination. In addition, please observe the relevant system messages.

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Reference images from previous examinations

CAUTION

The network connection may not be available continuously.

Reference images not available during intervention.

◆ Before beginning the intervention, the user should load the required images
from the network archive.

4.1.2 During the examination

WARNING

C-arm movements during surgery.

Risk of injury!
◆ Due to the maneuverability of the C-arm, collisions with other surgical devices
are possible if the device is not used as intended and in accordance with the
instructions in this manual.

WARNING

Instruments falling into the gap between the control unit and its housing.

Risk of short circuit, electric shock, and/or fire!

◆ Make sure no instruments, conductive material, or fluids penetrate into the
openings/joints between the control unit and its housing.

Patient position
Prior to the release of radiation, it is necessary to check whether the patient is
positioned correctly.

Image orientation
Ensure correct image orientation (accurate to side) on the monitor/on the hardcopy.

Data conformity
Correct orientation of image and patient data must be checked before storage.

Before terminating an examination and beginning work on the next patient, the patient
data should be verified.

The registered patient should be deselected at the end of the examination.

( Page 152 Closing the patient)

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Detector temperature

CAUTION

Detector temperature is not within recommended range.

Risk of limited image quality in the resulting X-ray images. Risk of X-ray
radiation exposure without any diagnostic value!

◆ Regularly check the temperature icon on the display.

Exceeding the critical temperature threshold is indicated by a system message on the left
monitor. In this case it is recommended to acknowledge the message and shut down the
system immediately to allow it to cool.

4.2 Preparing the system

CAUTION

Brake failure.

Crushing due to arbitrary movements!

◆ Before beginning the examination, perform the daily function and safety checks.

4.2.1 Removing/inserting the anti-scatter grid

Removing the anti-scatter grid reduces the radiation dose (as well as image quality), e.g.,
for a pediatric examination.

CAUTION

Changing the grid.

Crushing hazard between the detector housing parts.

◆ Note the hazardous zones/locations between the detector housing parts.

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CAUTION

Incorrect grid status: inserted, removed.

Radiation exposure without clinical benefit!

◆ Select the application according to your clinical procedure.

◆ Make sure that the current grid status meets your image requirements. The
imaging system indicates whether a grid has been inserted or removed.
◆ If necessary, insert or remove the grid manually.

Removing the anti-scatter grid

1 Unlock the anti-scatter grid by turning the fixing screw.

2 Carefully pull the anti-scatter grid from its holder.

3 Put the anti-scatter grid in a safe place.

4 Check that the icon for “Anti-scatter grid inserted” has a line through it.
This indicator appears on the left monitor and the control panels in the exposure
parameter area.

Inserting the anti-scatter grid

Once the pediatric examination is completed, you must reinstall the anti-scatter grid in
order to ensure optimum image quality during standard examinations.

1 Install the anti-scatter grid in the reverse order of its removal.

2 Check that the icon for “Anti-scatter grid inserted” does not have a line through it.
This indicator appears on the left monitor and the control panels in the exposure
parameter area.

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4.2.2 Protection against contamination and the penetration of

fluids
If a significant amount of fluid is expected during an examination, there is a risk of fluids
penetrating into the system. It is recommend to cover the relevant areas appropriately.

The C-arm can be covered completely or partially with a sterile disposable cover to
protect it against contamination ( Page 352 Sterile cover on the C-arm).

WARNING

Fluid penetration and contamination.

Damage to the flat detector

◆ Make sure that the detector is always covered by a disposable cover during
the examination.

4.2.3 Positioning the C-arm

Using the laser light localizer

Depending on the configuration of your Cios Alpha you can use the laser light localizer
as a positioning aid.

Switching on

◆ Press this button on the control panel.

Depending on the system configuration, all laser light localizers on the C-arm system
switch on.

The target crosshairs are displayed on the left monitor as long as the laser light
localizer is switched on (depending on the configuration settings).

Switching off

◆ Press the activated button on the control panel.

All activated laser light localizers are switched off automatically after 5 minutes.

Operating the laser light localizer at the C-arm (optional)

The flat detector housing can be optionally equipped with an additional button for
controlling the laser light localizers, thus allowing for a convenient workflow when
positioning the C-arm.

◆ Press this button on the front of the FD housing to switch the laser light localizers on
or off.

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Aligning the C-arm

CAUTION

Collision with other systems.

Risk of injury!

◆ Due to the maneuverability of the C-arm, collisions with other systems are
possible if the device is not used as intended and in accordance with the
instructions in this manual.

1 Align the C-arm system to the table and patient.

2 Release the relevant brake and move the C-arm to the required exposure position
( Page 72 Move C-arm).

3 Lock all brakes again.

4.2.4 Unlocking/locking radiation release

Your system has a lock-out option for radiation release to prevent unintentional release
of radiation, e.g., by accidentally pressing the footswitch.

The radiation lock can be optionally secured with a password so only authorized persons
can set the exposure parameters and release radiation.

You can set and change the password for locking radiation release in the configuration
( Page 248 Password for radiation release (optional)).

Unlocking radiation release

1 Press this button on the PREPARATION task card.
Without password protection on the radiation lock, exposure parameters can be set
and radiation released.

With radiation lock password protection, the password entry dialog is displayed.

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2 Enter the correct password (default setting: 0000).

Exposure parameter setting and radiation release are released.

– or –

Press this button if you want to keep the lock in place.

The dialog box closes without changes.

If you mistype your password, you can delete your entry with the Del button.

Locking radiation release

1 Press this button on the PREPARATION task card.

Without password protection on the radiation lock, exposure parameter setting and
radiation release are locked.

With password protection, the password entry dialog is displayed.

2 Enter the correct password.

Exposure parameter setting and radiation release are locked.

– or –

Press this button if you do not want to lock radiation release.

The dialog box closes without changes.

4.2.5 Selecting the application

The applications contain individual sets of examination settings tailored to various
medical application areas (such as General, Ortho).

The available applications are divided into application groups, for example, according to
hospital-specific requirements.

CAUTION

The image orientation is reset when changing the application group or application.
Risk of an incorrect decision during surgery!

◆ Be aware that the image orientation is reset when changing the application
group or application. All previous settings are lost.

For further information about applications and application groups, as well as their
configuration, see ( Page 248 Examination settings (PEX Editor)).

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Setting the application and application group

The application groups and applications are available in selection lists on the
PREPARATION task card.

1 Press the arrow button to open the Application group or Application selection lists.

2 Use the arrow buttons to scroll up and down in the selection lists.

3 Click the desired entry.

The exposure parameters including the operating mode are preset according to the
selected application.

4.3 Patient registration

Before you can examine a patient with your system, you must register the patient.

Registration means that you give your system all the information about a patient that it
requires for an examination.

Do not press the key combination Ctrl + Alt + Del.

CAUTION

Risk of mistaking patients.

The wrong patient is being treated.

◆ The user must ensure the correct patient is being treated before he or she is
registered on the system.

CAUTION

Patient ID already exists.

Misinterpretation of data of the examined patient if the selection is based
solely on the patient ID.

◆ Always use four-way identification [patient name, sex, date of birth, patient ID].
◆ Avoid mixing up patient data by using four-way identification. Selecting patient
data based on the patient ID alone is insufficient. Ensure the proper display of
parameters in the Worklist and in the Patient list.

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Depending on how registrations are organized in your hospital and how much time you
have for registration, you can choose between different patient registration procedures.

• Emergency registration

If a patient is admitted who is in an extremely critical condition and must therefore

be examined and treated immediately, select emergency registration. The patient is
registered with provisional data as an emergency patient. This reduces the time before
you can begin the examination to a minimum.

• Registration for the examination

However, if you want to register a patient for an examination, you first enter the
patient's data or select it from the database and then examine the patient.

• Preregistration
If you want to prepare the system to examine a patient at a later point in time, then
you can preregister the patient.

For example, in the morning you can enter the data of all the patients to be examined
during the day. When you want to begin an examination, simply select the relevant
data and edit them, if necessary. This saves time during the examination.

• HIS/RIS query

If your system is connected to a HIS/RIS system (hospital and radiology information

system), the patient can be registered for the examination though one of
these systems.

CAUTION

HIS/RIS configuration not harmonized.

Communication not possible.

◆ Do not use “Patient ID only” configuration within HIS/RIS because the imaging
system identifies the patient based on four pieces of data (patient name, ID, sex,
date of birth).

Patient registration is also possible on the monitor trolley when the C-arm system
is disconnected.

4.3.1 Emergency registration

An emergency registration is performed if a patient must be examined and treated
immediately, without any time to waste entering the patient’s data.

Emergency registration on the control panel

Emergency registration can be performed on the control panel at any time, regardless of
the processing step you find yourself in.

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PREPARATION task card

1 Change to the PREPARATION task card if necessary.

2 Press the "Emergency patient" button.

The PROCESSING task card is displayed on the control panel.

You can now start with the examination.

Keyboard mode If you are in a processing step requiring text entry, keyboard mode is set on the
control panel.

◆ Press this button in the symbol button bar.

The patient is registered as an emergency patient.

Keyboard mode ends.

Another patient registered If you perform emergency registration while another patient is registered, a
corresponding dialog box is displayed.

1 Select the desired options to conclude the examination ( Page 152 Closing
the patient).

2 Press OK to close the currently registered patient.

Emergency registration on the monitor

When you are editing patient data the Data Entry Dialog window is displayed on the
monitor. You can start emergency registration in that window with a click of the mouse.

◆ Click this button in the Data Entry Dialog window.

The patient is registered as an emergency patient.

The dialog window on the monitor closes.

Emergency registration with the hand switch or footswitch

Outside a running examination, you can perform emergency registration by activating
the hand switch or footswitch.

1 Make sure that there is not a patient registered for an examination.

2 On the hand switch, press the radiation release key once.

– or –

On the footswitch, press the radiation release pedal once.

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The patient is registered as an emergency patient.

Provisional patient data

During emergency registration, missing patient data are supplemented automatically.
An emergency patient is registered with the following data:

Data type Entry

Last name Emergency

First name Emergency if the patient ID has already

been entered
sequential number if the patient ID has
not already been entered

Date of birth Today's date

Sex Unknown

Patient ID E_sequential number

Make sure to correct the provisional patient data when the opportunity becomes
available ( Page 168 Correcting data).

4.3.2 Registering a new patient

If a patient has never been examined in your hospital or practice before, no data about
this patient will be stored on your system. Therefore all the required data for this patient
must be entered before an examination.

Opening patient registration

Open patient registration on the control panel in the PREPARATION task card.

1 Change to the PREPARATION task card if necessary.

2 Press this button.

The control panel switches to keyboard mode.

The Data Entry Dialog window opens on the left monitor.

Data Entry Dialog window

The mandatory fields for registration and preregistration are highlighted in
bold. Which fields are displayed and which are mandatory can be configured
( Page 236 Patient registration).

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PATIENT area Name, Patient ID, Age, and Sex of the patient are always mandatory entry fields. This
information uniquely identifies the patient in your databases.

Special notes:

• Patient ID
You can have a unique patient ID generated as long as no internal rules have been set
for the format.

• Date of Birth

Four digits must be entered for the year of birth.

If the date of birth is unknown, the patient's age is used to calculate a date of birth from
today's date.

• Age
If the date of birth has been entered, the patient's age is calculated from today's date
and entered.

STUDY area In this area, data from the HIS/RIS system (optional), if connected, are entered
automatically. The data are used especially to uniquely identify the study created for
the examination.

INSTITUTION area This area contains information regarding the examining facility and personnel. The
information can be helpful if the examination images are passed on to a different
organization for reporting.

Special notes:

• Institute Name

The institute name entered during configuration is entered here as the default.

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Application area This area shows the applications available for selection, divided into different application
groups ( Page 112 Selecting the application).

Entering data
The cursor is in the input field for the patient's name.

Making entries 1 Enter text and numbers using the keyboard in the control panel.
The characters entered are shown on the monitor and in the text field on the
control panel.

2 Use the mouse to select entries from the selection list.

You can manage the content of certain selection lists (drop-down combo boxes) in the
following way:

• To add an entry to the list, mark the text entered in the text field and press Shift +
↑ (arrow up) on the keyboard.

• To remove an entry from the list, select it from the list (text is marked in the text field)
and press Shift + ↓ (arrow down) on the keyboard.

Changing fields

◆ Use the Tab button (hold down the Shift button to go backwards) to switch to the
required field.

Generate a patient ID

◆ Press this button in the symbol button bar on the control panel.

– or –

Click the icon in the Data Entry Dialog window.

A new patient ID is generated based on the current date and time.

Correcting the entry

1 On the control panel press the arrow button of the text field to move the
cursor character-by-character.

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2 Press this button to delete the character in front of the cursor.

– or –

Mark the incorrect characters with the arrow buttons while holding the Shift button,
and overwrite with the keyboard.

Deleting all entries

◆ Press this button in the symbol button bar on the control panel.

All entries in the Data Entry Dialog window are deleted.

Completing registration
Once you have at a minimum completed the mandatory fields in the Data Entry Dialog
window, you can register the patient for the ensuing examination or preregister him or
her for examination later on.

Examining the patient

◆ Press this button in the symbol button bar on the control panel.

– or –

Click this button in the Data Entry Dialog window.

The Data Entry Dialog window closes.

The PROCESSING task card is displayed on the control panel.

You can start examining the patient.

Preregistering patients During preregistration the patient and entered data are stored locally. You can then
access the patient data again when you start the examination ( Page 121 Registering
patients from the worklist).

◆ Press this button in the symbol button bar on the control panel.

– or –

Click this button in the Data Entry Dialog window.

The patient is included in the Worklist.

The Data Entry Dialog window closes.

The PREPARATION task card is displayed on the control panel.

4.3.3 Registering previous patients

A patient who has already been examined in your hospital or practice is known to
your system.

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For the current patient registration you apply the saved information in the Data Entry
Dialog window.

Opening the Patient list

You open the Patient list on the control panel in the PREPARATION task card.
1 Change to the PREPARATION task card if necessary.

2 Press this button.

The control panel switches to keyboard mode.

The Patient list opens on the left monitor.

Patient not found If the patient you want is not displayed, a database filter may be on or the patient has
been deleted.

1 Set the filter criteria accordingly or switch off the filter. See ( Page 167 Filtering data)

2 If necessary, import the patient data from the archive. See

( Page 171 Importing data)

Checking/correcting patient data

Opening data

1 Use the arrow buttons or mouse to select the required patient.

2 Press this button in the symbol button bar on the control panel.

The data of the selected patient are transferred to the Data Entry Dialog window.

Editing data ◆ Check that the information in the Data Entry Dialog window is correct and add any
missing data ( Page 118 Entering data).

Wrong patient If you have selected the wrong patient:

◆ Press this button in the symbol button bar on the control panel.
All changes in the Data Entry Dialog window are discarded.

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The Patient list is displayed again.

Completing registration
Examining the patient

◆ Press this button on the control panel or click the button on the screen.

The Data Entry Dialog window closes.

The PROCESSING task card is displayed on the control panel.

You can start examining the patient.

Preregistering patients

◆ Press this button on the control panel or click the button on the screen.

The patient is included in the Worklist.

The Data Entry Dialog window closes.

The PREPARATION task card is displayed on the control panel.

Resuming a commenced study

If you cancelled a study with Close, you can continue this study later. Just select the
study, load the data into the Data Entry Dialog window, and then start the examination.
All newly generated images are saved in the existing study as a new series. Please note
that this is only possible if you have already acquired images in the commenced study.
An empty study cannot be used for registration.

1 Open the Patient list.

2 Select the corresponding study.

3 Transfer the data to the Data Entry Dialog window.

4 Register the patient for examination.

The PROCESSING task card is displayed on the control panel.

You may resume your study.

4.3.4 Registering patients from the worklist

The Worklist contains patients that were preregistered manually in your system and
automatically via the HIS/RIS connection.

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Updating the worklist

The Worklist is updated via the HIS/RIS system at regular intervals, and when the
Worklist is opened. You can also initiate the update manually, for example, when you
want to continue working without HIS/RIS connection.

◆ Press this button on the PREPARATION task card on the control panel.

Manage Tool is displayed on the left monitor.

Worklist complete

◆ Click this button in the Patient subtask card.

The Manage Tool closes.

The Worklist opens on the left monitor and is updated with the examinations
planned for your system.

Filtering the worklist If you are looking for a specific patient you can enter his name or you can query the
HIS/RIS for specific entries only.

1 Click this button in the Patient subtask card.

The Get Worklist Dialog window opens.

2 Enter the data you know as search criteria.

Possible placeholders: * stands for one or more random characters, ? stands for one
random character.

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Modality: The modality planned for the patient.

Not only today's worklist: Query for all scheduled appointments.

3 Click this button.

The Manage Tool closes.

The Worklist opens on the left monitor and updates. In addition to the patients
preregistered manually, only those HIS/RIS entries that meet the search criteria
are displayed.

Opening the worklist

You open the Worklist on the control panel in the PREPARATION task card, unless it is
already displayed due to a manual update.

1 Change to the PREPARATION task card if necessary.

2 Press this button.

The control panel switches to keyboard mode.

The Worklist opens on the left monitor.

Checking/correcting patient data

Opening data

1 Use the arrow buttons or mouse to select the required patient in the Worklist.

2 Press this button in the symbol button bar on the control panel.

The data of the selected patient are transferred to the Data Entry Dialog window.

Editing data 1 Check that the information in the Data Entry Dialog window is correct and add any
missing data ( Page 118 Entering data).

2 Press this button on the control panel or click the button on the screen to
confirm changes.

The Worklist is displayed again.

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For reasons of data consistency, some information in HIS/RIS entries cannot be

changed, such as the personal data of the patient.

Wrong patient If you have selected the wrong patient:

◆ Press this button in the symbol button bar on the control panel.

All changes in the Data Entry Dialog window are discarded.

The Worklist is displayed again.

Completing registration
◆ Use the arrow buttons or mouse to select the required patient in the Worklist,
if necessary.

Examining the patient

◆ Press this button on the control panel to examine the patient.

The Worklist closes.

The PROCESSING task card is displayed on the control panel.

You can start examining the patient.

– or –

Double-click the patient with the mouse.

Deleting a patient entry

As soon as the examination of a patient in the Worklist ends, the data saved in the study
is moved automatically to the Patient list.

If an examination for a patient is cancelled, you can manually delete the entry so that the
Worklist remains clear.

1 Use the arrow buttons or mouse to select the required patient in the Worklist,
if necessary.

2 Press this button on the control panel to remove the patient in question from
the Worklist.

4.4 Defining the examination settings

The standard exposure parameters are already set by default for the examination,
depending on the Application you have selected ( Page 112 Selecting the application).

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If these settings are appropriate for your examination, you can start the image
acquisition immediately on the Cios Alpha ( Page 138 Acquiring images).

The Application currently selected together with the patient data are displayed in the
left monitor on the upper left.

Make sure that the patient’s name on the monitor matches the patient to be examined.

4.4.1 Changing the fluoroscopy parameters

On the control units, you set the exposure parameters in the left area of the control
panel. Settings may be changed prior to each radiation release.

CAUTION

Incorrect exposure parameters.

Risk of unnecessary radiation exposure due to incorrect exposure parameters.

◆ Ensure the exposure parameters are correct.

Selecting the operating mode

The operating mode currently set is indicated by the button highlighted white. The
current operating mode is deselected when switching to another mode.

The operating modes can also be selected via the corresponding button on the
multifunctional footswitch (optional), if used. You can then release radiation again
right away. ( Page 339 Multifunctional footswitch)

Fluoroscopy Fluoroscopy operating mode enables real-time imaging which, for example, allows
viewing of moving objects.

◆ Press this button.

Fluoroscopy mode is selected.

The button is highlighted white.

Upon switching on the Cios Alpha, the operating mode configured as the
standard application, usually Fluoroscopy, is selected automatically by default
( Page 248 Examination settings (PEX Editor)).

Single image Single image operating mode enables an electronic instant image with the best
image quality.

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Do not use single image for final exposure. Use the LIH (Last Image Hold) image instead.

On activation of single image a short radiation pulse is released.

Please note that a Fluoro exposure with > 2fps has to be made before a single
exposure in order to set the exposure parameters (kV/mA) and thereby achieve good
image quality.

When acquiring single images, remember to keep the radiation release button pressed
(on the hand switch or footswitch) until the radiation indicator goes out.

◆ Press this button.

Single image operating mode is selected.

The button is highlighted white.

After complete image acquisition, radiation is automatically switched off, even if the
radiation release button remains pressed.

Digital Cine Mode (DCM) DCM operating mode enables a digital cine series for cardiac procedures.

◆ Press this button.

DCM operating mode is selected.

The button is highlighted white.

The maximum radiation time is 15 seconds for the special DCM Fluoro curves. Due to
technical reasons, the effective radiation time may exceed this value by fractions of
a second.

Subtraction (Sub) The subtraction technique enables an isolated display of the vascular system after
injection of the contrast agent by means of background subtraction ( Page 153 Digital
subtraction angiography (Sub)).

◆ Press this button.

Subtraction operating mode is selected.

The button is highlighted white.

Roadmap The Roadmap technique enables the user to position a catheter precisely in a blood vessel
under fluoroscopy. ( Page 155 Roadmap (Road))

◆ Press this button.

The Roadmap mode is selected.

The button is highlighted white.

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Please note that a Fluoro exposure with > 2fps has to be made before exposures using
subtraction or roadmap technique in order to set the exposure parameters (kV/mA)
and thereby achieve good image quality.

Setting collimators
The Cios Alpha uses the following collimators to collimate the X-ray beam:

• Rectangular collimator

The rectangular collimator provides radiation protection for the patient and all
persons participating in the examination.

• Slot collimator

The slot collimator is used primarily for collimation of the extremities.

CAUTION

Wrong collimator setting.

Dose not as required!

◆ The collimators need to be set so that at least one edge of the leaves is visible in
the fluoroscopy image. This must be checked daily.

Digital collimator function: The areas outside the collimated areas are automatically
blackened if so configured for the selected application. ( Page 255 Editing applications)

Collimation menu

◆ Press this button.

The Collimation menu opens.

The current collimation setting is displayed on the left monitor and in the image area
of the control panel.

When you release radiation, the collimators are in the position shown in the image.

When you open/close the rectangular collimator or move the slot collimator without
radiation, you can see the position of the collimator on the LIH image displayed with
lines superimposed.

Opening/closing the When switching on the Cios Alpha, the rectangular collimator automatically opens to
rectangular collimator full format. Smaller collimation produces less scatter radiation and therefore better
image contrast.

◆ Press one of these buttons.

The rectangular collimator opens/closes.

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Opening/closing the slot Collimation enhances image contrast and reduces scatter radiation. Direct radiation that
collimator passes the soft tissue laterally is reduced to such an extent, that differences in brightness
do not disturb when images are viewed on the monitor.

The position of the left and right slot collimator blades can be changed jointly
(symmetric) and individually (asymmetric).
1 Press one of these buttons.

The slot collimator opens/closes symmetrically.

2 Press one of these buttons for the left or right slot collimator side.

The corresponding blades extend/retract on one side.

Rotating the slot collimator By rotating the slot collimator, the collimated field can be quickly oriented to the direction
of the anatomy under examination (e.g. the extremities).
◆ Press one of these buttons.

The slot collimator rotates to the left/right.

Resetting the collimators

◆ Press this button.

The collimators are reset to full format.

Adapting the collimation in enlarged preview

The enlarged preview allows changing the collimator settings on LIH images and during
all live 2D fluoro scenes.
1 Open the Collimator menu of the enlarged preview.

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The current positions of the collimator blades are drawn in the image, represented
by a square (rectangular collimator) and two parallel lines (slot collimator).

2 Press the icon of the rectangular collimator and drag the square up/down to open/
close the rectangular collimator.

3 Press an icon of a slot collimator and move the line(s) by dragging to change the
position of the respective slot collimator blade.

Press an icon of a slot collimator and rotate the line(s) by dragging to change the
orientation of the slot collimator blades.

4 Press this button to reset collimation. This will open the collimators completely.

Selecting the dose rate level

You can choose between three dose levels (deviating from the current user program).

The dose level currently set is displayed at the Dose button of the control panels and at
the left monitor.

When selecting different dose levels, please note that additional specific parameter
settings, such as k factor and pulse rate, change automatically.

Dose menu
◆ Press this button.
The Dose menu appears.

The current setting is highlighted white.

Selecting the dose level

◆ Select the required dose with the buttons.

Dose levels of low, medium, and high may be set.

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If the maximum skin dose is exceeded at the highest dose level, the corresponding
button is called "High level". The maximum duration of a fluoro scene is limited to 30
s. The button and the display on the monitor are marked with a warning symbol.

Switching on metal correction

Metal correction is designed for examinations with metal parts in the measurement
range (e.g., larger, non-standard implants). When activated, the contrast and brightness
settings are adjusted accordingly and the automatic dose rate control is improved.

◆ Press this button.

The button is highlighted white.

Selecting the motion/noise filter

By using noise filters with motion detection, you take into account the influence of
movements when filtering noise. Image integration depends on the preset k factor
(depending on the operating mode up to max. k = 16), which is adapted according to the
selected motion/noise filter.

k factor: The k-factor is used for image processing/image integration. For image
integration a number of k exposures are integrated into one image by sliding
averaging; the k factor can be selected between k = 1 and k = 16 and can be assigned
to an examination set.

Motion noise filter menu

◆ Press this button.

The Motion Noise filter menu is displayed.

The current settings are highlighted white.

Motion detection Motion detection is used to establish whether the maximum number of images (for
still objects) or a lower number of images (for moving objects) should be used for
image integration.

◆ Press one of these buttons.

Off: Image integration is independent of movements in the image with
preconfigured k-factor.

On: Image integration takes place only if movements are detected in the image.

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Cardiac filter The Cardiac button is used for examinations requiring particularly high temporal
resolution. It reduces the k factor to a minimum to reduce blurring. It may however also
increase noise.
◆ Press this button.

No image integration occurs. In this way rapidly occurring processes (e.g. beating
heart) can be best shown.

Averaging live image By fine adjusting the averaging, you take into account the motion frequency of the object
to be examined. An integration factor is applied to the k value that results for the selected
motion detection.

◆ Press a button in the Noise filter live image area.

Low: A low integration factor is selected (for recording fast-moving objects;

default: 0.7).

Medium: No change in the k value (integration factor = 1).

High: A higher integration factor is selected (for very slow movements; default: 1.4).

Noise filter LIH A separate setting for image integration is available for the LIH (Last Image Hold) image.
The values to be set and the functionality is the same as for Noise filter live image.

◆ Press a button in the Noise filter LIH area.

Possible settings: Low, Medium, High.

Selecting the input format (Detector zoom/magnification)

Three different zoom levels are available. This sets the input format for the subsequent
image acquisition. The input format is the size of the detector area that is exposed and
then fills the screen when displayed on the monitor.

Zoom level Mag 0 Mag 1 Mag 2

Input format (20 cm x 20 20 cm x 20 cm (full format) 15 cm x 15 cm 10 cm x 10 cm

cm detector)

Input format (30 cm x 30 30 cm x 30 cm (full format) 20 cm x 20 cm 15 cm x 15 cm

cm detector)

Magnification menu

◆ Press this button.

The Magnification menu opens.

The current input format level is displayed on the left monitor and in the image area
of the control panel.

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Select the zoom level

◆ Select the required zoom level with the keys.

The input format display is updated accordingly.

Setting the pulse rate

Depending on the configuration level, you can select from among up to 9 different pulse
rates during the examination. The respective set value is displayed on the control panel
using the Pulse rate button.

Pulse rate menu

◆ Press this button.

The Pulse rate menu opens.

The current setting is highlighted white.

Selecting the pulse rate

◆ Select the pulse rate required with the corresponding button.

The pulse rate changes accordingly.

Setting the X-ray parameters manually

You can change the default X-ray parameters manually with the +/- buttons for kV/mA or
kV/mAs (for single image operating mode).

Automatic dose rate control: Using automatic dose rate control (ADR), the kV/mA
values or kV/mAs values are regulated so that the mean value of the image gray values
is kept constant largely independently of the object thickness and position. This ensures
optimal image quality for on-screen evaluation.

Techlock mode

Techlock mode is provided as a quality control mode which enables selection of x-ray
parameters by a manual control

The current automatic dose rate control status can be read on the control panel using the
Tech lock button.

(1) ADR activated (kV/mA are automatically regulated)

(2) ADR locked (kV/mA remain constant for the current values)

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The system possess an automatic metal correction which is designed for examinations
with metal parts in the measurement range. The metal correction parameters are
included in the Application settings. For example, the contrast and brightness
settings are adjusted accordingly and the automatic dose rate control is improved.

If the image quality is not sufficient, please use the additional Metal correction or
Tech lock functionality.

Activating Tech lock Stop When metallic objects (e.g. intermedullary nails) are introduced into the beam path or
when examining objects of varying density (e.g. hip prosthesis) under fluoroscopy, it is
recommended that you set the kV just established with the Tech lock button at the start
of fluoroscopy.

The automatic dose rate control (ADR) must remain activated during
interventional procedures.

1 Press this button.

The Tech lock menu opens.

2 Press this button.

The stop function is activated and the Stop button is highlighted white.

Automatic dose control is disabled.

The +/- buttons for kV/mA or kV/mAs are enabled.

Do not switch between Fluoroscopy and Single Image operating modes while Tech
lock Stop is active, because with Tech lock Stop the image brightness cannot be
adjusted to the different dose levels in the two operating modes.

Changing the X-ray Activating Tech lock Stop enables you to manually set kV/mA or kV/mAs.
parameters manually
The set values are displayed on the control panel.

(1) Display of kV/mA (mAs) and pulse width in the Tech lock menu
(2) Display of kV/mA (mAs) in the exposure parameter area

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◆ Press the +/- buttons.

The values for kV/mA or kV/mAs increase or decrease.

Pressing the button for an extended period continually increases or decreases the
corresponding X-ray parameter.

Once the upper or lower limit of the setting range is reached, an audible tone is
emitted. Pressing the button again has the same effect.

The mA values assigned to the kV values result from the fluoroscopy curves
( Page 285 Curves and diagrams).

Adjusting dose control and / or contrast enhancement to an

individual region of interest
During examination: Even after running the complete dose control phase, it is
possible that the image impression for the relevant anatomical area (ROI) will not
meet requirements.

The Spot/Adapt function enables the dose control focus to be placed on this required
area. With the function switched on, the user either drags the focus area (shown as an
orange circle in the image) on the LIH in the enlarged preview image to the appropriate
area, or taps the appropriate area.

The next time radiation is released, automatic dose control will weight this selected area
the highest and automatically optimize the dose for this area.

In addition to dose, brightness and contrast are also adapted to this area to optimize the
image impression.

The resulting parameters are carried over to subsequent exposures until either a new
focus area is selected or the Spot/Adapt function is disabled.

During image review: Spot/Adapt can also be used on saved images to optimize
brightness and contrast.
1 Open the Spot/Adapt menu of the enlarged preview.

2 Press this button to activate Spot/Adapt.

The circle marking the spot position is displayed in the center of the image.

If the image has been zoomed and/or panned, the ROI circle may lie outside the image
segment. Touch the enlarged preview image to move the circle into the visible area.

3 Drag the circle to move the spot to the required position in the image.

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Spot/Adapt will be applied to all subsequent images.

4 Press this button to deactivate Spot/Adapt.

4.4.2 Setting the image parameters

On the control units, you set the image parameters in the PROCESSING task card in
the right area of the control panel. Changing the settings impacts the image currently
displayed (if applicable) and any images acquired thereafter.

Selecting the image orientation

It may be necessary to rotate and/or flip the image so that it appears in the required
orientation on the monitor.

Object display on the monitor depends upon the C-arm system position relative to
the patient.

CAUTION

The image orientation may be inverted, for example, if 2D images are displayed on
external viewers.

Risk of an incorrect therapeutic decision.

◆ The operator must apply due diligence to correctly identify the 2D

image orientation.

CAUTION

Inverted image orientation.

Incorrect intervention decision!

◆ It is recommended to mark the patient position using lead letters.

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Standard image orientation

(1) Right side of patient

(2) Left side of patient

Rotating/flipping images
The current image rotation and -flip settings are displayed in the image area of the
control panel.

The rotation angle ranges from 0° to 359°.

If the flip or rotate setting is changed, this will also apply for the next image, even if
changing the setting is done without an acquired image.

Rotation Flip menu

◆ Press this button.

The Rotate Flip menu appears.

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Selecting the image rotation

1 Use these buttons to set the angle of rotation in 90° increments.

– or –

Press one of these buttons.

With each short press of the button, image rotation increases 1° in the
corresponding direction.

Pressing the button for an extended period continually increases or decreases the
angle of rotation.
2 Press this button to reset the angle of rotation to 0°.

Selecting image flip

◆ Press one of these buttons.

Vertical/horizontal image flip is activated.

Rotating/flipping images in enlarged preview

1 Open the Rotate Flip menu of the enlarged preview.

2 Press Help for help on how to drag to rotate and flip the image, if required.

3 To rotate the image, tap a point inside the image area (marked dark grey in the
gesture help image) and drag clockwise or anti-clockwise.

4 Press this button to reset image rotation to 0°.

5 To flip the image vertically, tap a point close to the left edge of the image area
(marked light grey in the gesture help image) and drag up or down.

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6 To flip the image horizontally, tap a point close to the bottom edge of the image area
(marked light grey in the gesture help image) and drag left or right.

4.5 Acquiring images

All further steps of the examination are performed at the C-arm system. For
detailed information on operating the C-arm, hand switch, and footswitch, see
( Page 51 System Description).

The registered patient's last name, first name and date of birth appear in the upper
control area of the left monitor.

◆ Prior to releasing radiation, make sure that the registered patient and actual patient
are the same.

CAUTION

Inverted image orientation.

Risk of an incorrect decision during surgery.

◆ Prior to releasing radiation, the user must ensure the correct patient position
with respect to the X-ray beam.

4.5.1 Releasing radiation

◆ Release radiation with the hand switch or footswitch.

As long as radiation is applied the current fluoro image is displayed on the left
(live) monitor.

After radiation release switch is pressed the system will play an acoustic feedback
sound until the radiation is started.

As long as radiation is applied, a sound is played back which differs depending on the
selected operating mode or dose:

• Sound 1 for Fluoroscopy, Roadmap

• Sound 2 for High Level Fluoroscopy, High Level Roadmap

• Sound 3 for Single image, Digital Cine Mode, Subtraction

Please keep the radiation release switch pressed until radiation has been released and
a usable image is displayed.

CAUTION

Defective imaging system hardware.

Risk of X-ray radiation without a stored image!

◆ In case of image failures stop exposures and switch off the system.

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CAUTION

Because of a technical error the acquisition is not stopped or there is an unintended

release of radiation.

Risk of unnecessary radiation exposure!

◆ Press the OFF button on the monitor trolley, even if the EMERGENCY STOP button
has already been pressed. Radiation terminates immediately.

Dose regulation indicator

At the start of radiation, the set dose value is regulated automatically to the object
located in the beam path. During this phase the image impression can change gradually.
The dose regulation indicator is displayed as a thin orange frame around the radiography
image for as long as this process takes.

Display: “Dose regulation running”

When the control phase process is completed, the orange frame disappears.

Display: “Dose regulation successfully completed”

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The dose regulation indicator provides orientation for the minimum period for which the
user should release radiation to obtain a cleanly adjusted radiographic image.

The dose regulation indicator typically appears after every change of C-arm position
where the automatic dose control has to adapt the dose to the new situation.

The dose regulation indicator is seen most frequently when working exclusively in
single image mode and simultaneously changing the C-arm position. To avoid the poor
image impression that is likely to occur in this procedure, it would be better for the user
to work in fluoro mode where possible and allow the system to adjust accordingly.

Even after running the complete dose control phase, it is possible that the image
impression will not meet requirements. In this case the user should implement suitable
measures to adjust the image impression accordingly. (for example: change the
application, modify the dose level, use Tech lock Stop, Spot/Adapt, etc.).

The indicator also remains on continuously where necessary when the system is working
at its control limit. For the available kV range, see ( Page 313 X-ray generator).

If the image impression still does not meet requirements, the user should implement the
following measures where possible: for example, change the application to an “adipose”
program, reduce the dose level, reduce the magnification level, avoid frame rates > 10
f/s.

Displaying fluoroscopy images

In the image area the fluoroscopic images are displayed during and after exposure.
Additional information may be shown as image text, depending on the configuration
( Page 242 Image display and print properties).

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(1) Information on kV and mA

(2) Window value and LUT information

Live images As soon as the exposure (i.e. radiation) starts, the current fluoroscopic images (live
images) are displayed on the left monitor and the control panels.

Last Image Hold (LIH) The last image hold (LIH) is displayed as soon as the exposure has ended.

Confirming a warning signal

After 5 minutes of uninterrupted fluoroscopy time, a warning signal sounds. However,
this can be reset on the control panels. After 10 minutes of uninterrupted fluoroscopy
time, radiation is terminated. However, it can be released again.

These settings are country-specific and can be changed by Siemens Healthineers

Customer Service in accordance with the applicable regulations.

◆ Press the reset button (alarm icon flashes).

The audible warning signal is deactivated.

The fluoro timer is reset.

Temperature monitoring
If the system is used intensively over an extended period, the X-ray tube and single tank
can become very hot.

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Single-tank temperature The current thermal capacity of the single tank is shown by an 11-segment bar display
on the left monitor:

The length of the bar indicates the relative temperature load of the X-ray system.

X-ray tube temperature The X-ray tube temperature status is displayed on the left monitor as follows:

If the temperature is normal, a green tube symbol appears on the color monitor.

If the tube is heated, an orange tube symbol appears on the color monitor.

If the tube temperature is critical, a red tube symbol with an exclamation point appears
on the color monitor.

To prevent overheating, the Fluoro power will be limited.

Radiation information

The DAP (dose area product) is measured by a dedicated DAP chamber which is located
in the tube housing. The Air Kerma and the Air Kerma rate are calculated by the
system taking into account collimator positioning and patient entrance reference
point (PERP). The dose indicators (DAP, Air Kerma and Air Kerma rate) show ≤25%
deviation between measured and displayed values.

The radiation data are shown on the control panels and on the left monitor. The
information is updated with every release of radiation.

Here, the entire fluoroscopic time since the start of the examination of a patient
is displayed.

The cumulative dose area product for the current patient is displayed if the dose
measurement chamber is installed.

As an alternative: Display of the air kerma value (2) and cumulative air kerma value (1).
These data appear on the left monitor.

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The reference location for determining the air kerma values with the dose
measurement chamber is 30 cm in front of the detector input. The reason for
this convention is that in typical applications the object to be examined is located
approximately 30 cm in front of the flat detector.

Depending on country-specific regulations, you can have Siemens Healthineers

Customer Service change the display so that it indicates the air kerma and cumulative
air kerma value instead of the dose area product.

4.5.2 Saving and displaying images

In Fluoroscopy, Subtraction, and Roadmap operating modes, images can be saved
manually during the examination. Images that you want to print out later have to
be saved during the examination. Images printed directly during the examination are
saved automatically.

If the application used is configured such that all images are saved automatically,
manual saving is not necessary and therefore not possible.

Saving images/scenes with the footswitch is also possible when the pedal allocation is
configured accordingly.

Images/scenes can always be saved via the corresponding button on the

multifunctional footswitch (optional). See ( Page 339 Multifunctional footswitch).

Storing images (during radiation)

◆ Press this button on the control panel.
– or –

Press this button on the hand switch.

The current image (or the subtraction image in Sub/Roadmap mode) is stored in
the local database. All images saved in the course of an examination are stored as
a series.

The saved fluoro image is displayed on the right (reference) monitor. This does not
occur if a second video source is displayed on the right (reference) monitor (refer to
( Page 148 Loading images from an external video source)).

Storing images (after radiation)

◆ Press this button on the control panel.

– or –

Press this key on the hand switch (press and hold < 2 seconds).

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The displayed image (LIH) is stored in the local database.

The LIH is displayed on the right (reference) monitor.

Holding the key for > 2 seconds: Saves the scene last recorded (LSH).

Saving and reviewing a scene

In the fluoroscopy, subtraction and Roadmap operating modes, scenes can be saved and
reviewed (Last Scene Hold) during the examination.

Saving the scene

◆ Press this button on the control panel.

– or –

Press this key on the hand switch (press and hold > 2 seconds).

The current scene (LSH) will be stored in the local database. In case of a restricted
review range, images are saved from the starting point to the end point.

The LSH is displayed on the right (reference) monitor.

Holding the key for < 2 seconds: Saves the image last recorded (LIH).

Reviewing a scene

1 Press this button.

The Cine replay menu appears.

2 Press the activated Pause button to start (replay speed matches the storage rate).

During replay the Pause button changes to a Start button.

3 Replay at half/normal/double speed.

4 Previous/next single image.

5 Play previous/next available scene.

6 Establish starting point and end point for replay.

The corresponding image number is displayed in the respective button.

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7 Switches automatic cine replay on/off.

If Autoreplay is configured in the application used, cine replay is started automatically

at the end of the exposure.

Reviewing a scene in enlarged preview

1 Press the activated Pause button of the enlarged preview to start cine replay.

During replay the Pause button changes to a Play button.

2 Press the Play button to pause replay.

The Play button changes to an activated Pause button again.

Reviewing a scene (Digital Cine Mode)

Exposures in the DCM operating mode (Digital Cine Mode) can be played back as a movie
by using the tools of the Cine replay menu. ( Page 144 Reviewing a scene)

Changing the image display

There are tools available on the control panels for subsequent optimization of the image
display. For detailed information see ( Page 175 2D image processing).

1 Edge enhancement (4 levels).

2 Brightness/Contrast, image inversion.

3 Zoom/pan image/set shutter.

4 Rotate/flip an image.

CAUTION

Processing images by changing the image display.

Loss of image quality by artifacts.

◆ Use care when changing the image display settings.

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Recording video
Parallel to the display on the left monitor, you can save scenes to DVD as video. The
MPEG-4 standard DVD video format with 512x512 matrix size is supported.

The resulting DVD is suitable for use with a DVD player.

DVD recording is not suitable for diagnosis because the images are stored in a
compressed (lossy) format and archiving requirements are not fulfilled.

Starting recording 1 Insert an empty DVD into the DVD drive.

Supported formats: DVD-R, DVD+R

After inserting a DVD when a recorder license is available, the monitor queries
whether the DVD should be used for recording.

2 Change to the EXTERNAL task card.

3 Press this button.

Ending the recording

1 Change to the EXTERNAL task card if necessary.

2 Press this button.

3 After the write process, remove the DVD from the drive.

4.5.3 Using reference images

In addition to the live images on the left monitor, selected images, e.g. images used for
comparisons, can be displayed on the right monitor.

Transferring Images
Automatic During saving, an image or scene is transferred automatically to the right monitor:

1 Save the image manually with the Store button (during/after radiation)

The displayed image/LIH is saved and transferred.

– or –

Save the image automatically ("Automatic save" is active)

The LIH is saved and transferred after radiation ends.

2 Save the scene manually with the Store cine button

The LSH is saved and transferred.

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– or –

Save the scene automatically ("Automatic save" is active)

The LSH is saved and transferred after radiation ends.

Manual Using the Transfer A to B function you can transfer an image to the right monitor during
or after radiation, without saving it simultaneously.
◆ Press this button.

The displayed image is transferred.

Please remember that the transferred image has not been saved, and will be lost
permanently if overwritten by another image.

Scrolling through images

If the "Automatic save" function is active or you have saved several times, images in
addition to the displayed image are available on the right monitor.

1 Scroll to previous image/to previous scene.

2 Scroll to next image/to next scene.

Holding the reference image

The Hold reference function allows you to select a particular image to permanently
display as the reference image on the right monitor.

1 Press this button.

The display on the right monitor is “frozen”.

The transfer of additional images and scrolling to other images is disabled on the
right monitor.

2 Press the button again to cancel Hold reference.

Hold reference is automatically turned on for the first image transferred to the right
monitor using the Transfer A to B button.

Hold reference is cancelled automatically when switching to image overview display

( Page 176 Displaying the image overview). Hold reference is reestablished once the
image overview display is closed.

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Loading images from an external video source

If suitable video sources are connected to your system (such as endoscope or
microscope), you can display the recorded images on the right monitor for reference.

Selecting the video source

1 Change to the EXTERNAL task card.

2 Press this button.

The video inputs of your system are checked according to the connecting
video sources.
3 Keep the button pressed until the required video source is reached.

Displaying images

◆ Press this button.

The image recorded from the video source is displayed on the left monitor if radiation
is not being released.

The image is saved to the local database as "CAP image" under the current study of
the registered patient.

4.5.4 Using “Cios OpenApps” (optional)

Cios OpenApps* allows 3rd party vendor applications to run on your system providing
more integration and streamlined workflows between the imaging system and the 3rd
party applications. The 3rd party applications are installed on a separate application PC
which is connected to the monitor trolley.
* The Cios OpenApps is not commercially available in all countries.

The Cios OpenApps option is not available if the Video Manager option is installed.

If Cios OpenApps is installed, the EXT./OPEN APPS task card is displayed instead of the
EXTERNAL task card.

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Selecting an application
Only installed and licensed Cios OpenApps applications can be selected and started.
Selecting a Cios OpenApps application has to be done before starting the examination. It
is not possible to change the Cios OpenApps application during an ongoing examination.

The applications installed on the system are available in the selection list of the EXT./
OPEN APPS task card.

Instructions on installing Cios OpenApps applications are given in the separate

operator manual “User Administration Guide”. To have a new application installed,
please contact your system administrator.

1 Before you register a patient, change to the EXT./OPEN APPS task card.

2 Select the required application.

Transferring images to the application

After activation, the user interface of the Cios OpenApps application will be displayed on
the right monitor.

The system automatically closes the application when an emergency registration is

performed or an acquistion is started. However, you can configure the Cios OpenApps
application to resume automatically after the acquisition has ended.

1 Change to the PREPARATION task card and register the patient.

2 Define the examination settings and acquire images.

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If images are acquired while the application PC is being restarted, the images are not
available for transmission to the Cios OpenApps application. In this case, wait until the
application PC has completely rebooted.

3 Change to the EXT./OPEN APPS task card.

4 Press this button to activate automatic return to the Cios OpenApps application after
completion of an acquisition.

5 Press this button to start the application.

A message box is displayed on the control panels notifying that the application is
being started.

The virtual keyboard appears on the control panels instead of the task cards.

6 Press this button on the virtual keyboard to transfer the current image to the Cios
OpenApps application on the right monitor.

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Example of a Cios OpenApps application with an image loaded

The Send to Open Apps button is displayed as active even if no image is available.

Terminating the application

You can terminate the Cios OpenApps application in the following ways:

◆ Press the Close button on the virtual keyboard.

– or –

Press the radiation release key or pedal once.

If the radiation release key or pedal is pressed a second time, radiation will be released.

4.6 Ending the examination

After you have completed your exposures, the last acquired image is displayed on the left
monitor. Now you finish the examination of the current patient.

If you want to examine the next patient immediately afterwards, you can register
that patient straight away. In this case the examination of the current patient is
automatically finished.

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4.6.1 Closing the patient

Closing the patient ends the current examination. The patient data and images saved in
a study in the local database are moved to the Patient list.

1 Press this button on the bottom right of the control panel.

The Close menu appears.

2 Select the desired options.

Print rad. summary: Prints the radiation report on the default printer.

Export rad. summary: Sends the radiation report to the default address for export.
3 Press this button.

The examination is concluded. The MPPS documentation is automatically sent to the

HIS/RIS or a network address established for this purpose.

The patient data and images are cleared from the monitors.

– or –

Press this button to continue the examination with the registered patient.

4.6.2 Examining the next patient

1 Change to the PREPARATION task card if necessary.

2 Register the next patient for examination ( Page 113 Patient registration).

Another patient registered

If another patient is still registered the New patient menu is displayed.

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1 Select the desired options to conclude the examination ( Page 152 Closing
the patient).
2 Press OK to close the currently registered patient.

The new patient is registered for examination.

4.7 Performing special examinations

The following optional operating modes require special procedures deviating from the
standard examination:

• Subtraction angiography (Sub)

• Roadmap (Road)

• Using live graphic overlays

• Pediatric applications

After incorrect operation, it may be necessary for the user to repeat certain
procedures, e.g. administering of contrast agent.

4.7.1 Digital subtraction angiography (Sub)

Cios Alpha provides the Digital Subtraction Angiography mode and fulfills the German
standard DIN 6868-150 with the Energy Storage Unit option only.

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During the examination, images without contrast agent (mask) are continuously
subtracted from images with contrast agent and displayed on the monitor. Depending
on the contrast agent flow, they display the relevant vascular segment without
superimposition in real time.

Progression
Subtraction angiography is divided into three phases:

• Phase A

Time until the mask is completed (2.6 seconds)

• Phase B1

Time from the "inject" display on the monitor until the contrast agent has reached the
examination region

• Phase B2
Time of the actual exposure of the examination region

Performing subtraction angiography

✓ The patient to be examined has been registered.

1 Select an application with the suffix “_DSA”.

Please note that DSA is performed only if applications with suffix “_DSA” are selected.

2 Press this button.

Subtraction operating mode is selected.

Phase A

◆ Release radiation with the hand switch or with the assigned footswitch.

During the generation of the mask the native image is displayed on both monitors.

Phase B 1 Keep the exposure release button pressed.

2 Inject the contrast agent as soon as the syringe symbol appears on the screen and
control panel.

The corresponding subtraction image is displayed on the control panel and

left monitor.

In the native image on the right monitor you can see the continuous filling of the
blood vessel with contrast agent.

Keep the radiation release button pressed until the vessel is filled with contrast agent.

Depending on the setting of the Landmark function, a certain percentage of

anatomical background is displayed in the subtraction images.

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Fill image ◆ Let go of the radiation release button.

After radiation has been switched off the maximum fill image is calculated and displayed
on the left monitor.

The vessels are highlighted in the native image on the right monitor.

The mask (phase A), subtraction series (phase B) and the fill image are
saved automatically.

4.7.2 Roadmap (Road)

In the first step of the Roadmap examination, the fill image is created as a mask from a
normal subtraction (phase A and phase B).

In the second step, the display of the vessel into which the catheter is to be positioned
is superimposed by current fluoroscopic images (phase C).

Fill image available

You can use the existing fill image if you have already performed a subtraction
angiography during the current examination ( Page 156 Using the fill image from
subtraction angiography).

The availability of the fill image is shown on the Road button and on the footswitch icon
on the monitor. In that case, the first step of the Roadmap examination is not required.

A previously created fill image can also be used if you have switched to a different
operating mode (such as single image).

Generating a new fill image

If there is no suitable fill image (e.g. from a previous subtraction angiography), you have
to generate a new one.

✓ The patient to be examined has been registered.

1 Make the necessary settings for the examination. ( Page 124 Defining the
examination settings)

2 Press this button.

The Roadmap mode is selected.

Phase A

◆ Release radiation with the hand switch or with the assigned footswitch.

During the generation of the mask the native image is displayed on both monitors.

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Phase B 1 Keep the exposure release button pressed.

2 Inject the contrast agent as soon as the syringe symbol appears on the screen.

In the native image on the right monitor you can see the continuous filling of the
blood vessel with contrast agent.

The corresponding subtraction image is displayed on the left monitor.

Keep the radiation release button pressed until the vessel is filled with contrast agent.

Fill image 1 Let go of the radiation release button.

Radiation is stopped.

The fill image is calculated and displayed.

2 Start positioning the catheter ( Page 157 Positioning the catheter (phase C)).

Using the fill image from subtraction angiography

✓ Subtraction angiography (Subtraction operating mode) was performed at some
point during the current examination.
1 Press this button.

The Roadmap mode is selected.

2 Start positioning the catheter ( Page 157 Positioning the catheter (phase C)).

If you press the Sub button, the existing fill image is discarded. You will then have to
regenerate the fill image.

Manually selecting the fill image

✓ A subtraction data set (subtraction or Roadmap operating mode) was generated in
the current examination.

Fill image with another mask To calculate a new fill image you have to determine a suitable subtraction mask that can
be used.

1 Press this button.

The Select mask menu opens.

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2 Move the slider to the left/right to select another mask image.

Pressing the arrow repeatedly takes you incrementally from image to image. The fill
image is recalculated automatically.

Fill image from image To calculate a new fill image you have to determine a suitable selection of subtraction
selection images that can be evaluated.

1 Press this button.

The Fill image menu opens.

2 Display the subtraction series images, and use the buttons to set the first/last image
you select as the new start point/end point.

The Fill image menu displays the images numbers for the start point and end point
of the limited series range.

A new fill image is calculated and displayed based on the image selection.

3 Press this button to apply the fill image.

The Fill image menu closes.

Selecting a different fill image If multiple fill images have been calculated you can select the most suitable image for
phase C.
1 Press this button.

The Fill image menu opens.

2 If necessary, repeatedly press one of the buttons to select the fill image required.

Positioning the catheter (phase C)

If the vessels are easily discernible, position the catheter in the fill image
under fluoroscopy.

1 Release radiation with the hand switch or with the assigned footswitch.

2 Position the guidewire or the catheter under fluoroscopic control.

The right monitor shows the fluoro image (native).

The left monitor shows the subtracted Roadmap image with catheter.

You can repeat fluoroscopy as often as needed while you insert the catheter.

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4.7.3 Using graphics overlays

The lines drawn in an ongoing examination can be transferred to the subsequent live
images. Such graphic overlays are used, for example, in orthopedics, traumatology as
well as in subtraction and roadmap examinations. For example, lines can be drawn into
fill images to support the treatment of abdominal aortic aneurysms.

WARNING

An annotated image with graphic overlay lines is displayed. Following system

and/or table or patient movements and/or image modifications, subsequent
images may not match the overlay line displayed due to projective changes.

Incorrect interpretation of the display and resulting incorrect decision

during operation!
◆ The graphic overlay line is displayed until the user actively turns it off. This is
done independently of any changes (for example, movements, operating mode
changes, image modifications). The user must ensure that the displayed overlay
line matches the current, underlying image (for example, display of anatomical
structures via the label function and/or use of contrast agent).

Live graph overlay menu

1 Display the required image.

Creating live graphic overlays on imported external images is not possible.

2 Press this button.

The Live graph overlay menu is displayed.

Drawing lines
You draw the lines as a polygon where each change in direction creates a vertex in
the image.
1 Press this button to set the starting point and vertices at the respective mouse
pointer positions.

2 Press this button at the required end point.

The new line is shown as a dotted line in the image.

If a graphic overlay was already used in the previous image, the corresponding lines
are displayed as continuous. The old overlay is replaced by the newly drawn in lines in
the following images.

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Deleting points
If a point has been placed incorrectly, it can be deleted immediately after being drawn
as long as the end point has not been set.

◆ Press this button.

The last point set is deleted from the image.

Pressing the button again deletes the previous point.

You can continue drawing the line.

Postprocessing lines
Postprocessing via the Live graph overlay menu is possible only for newly drawn
lines (dotted). A previously used overlay (solid lines) can be post-processed using the
Measure Annotate menu see ( Page 191 Evaluating images).

1 Move the mouse pointer to the line or a point to select the given graphic object.

2 Press this button.

Now you can move (arrow buttons) or delete (Delete selected button) the selected
point or the complete line.

Deleting everything
◆ Press this button.

The newly drawn graphic overlay (dotted lines) is deleted.

4.7.4 Using the Target Pointer (optional)

This application enables the automatic detection of K-wires and displays the trajectory
as a projection to the opposite edge of the image. Displaying the trajectory is intended
to help the surgeon to better predict the position of the K-wire in an early phase of
the insertion.

For Single Image and Fluoro acquisition modes, an additional button is available in the
PROCESSING task card for activating the Target Pointer application.

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CAUTION

Time gap between display of K-wire including overlay grafic and real moved K-wire.

Risk of wrong interventional decision.

◆ Duty of care for operator, that he/she shall be aware of this possible mismatch.

CAUTION

Overlay itself may hide K-wire in live X-ray image (depends on thickness of K-wire
and overlay configuration).

Risk of wrong interventional decision.

◆ Target Pointer can be switched-off (toggle ON/OFF) to allow free view on X-ray
live image.

1 Press this button to switch the Target Pointer on.

The trajectories of all detected K-wires will be displayed in Single Image or Fluoro
acquisition mode.

2 Press the activated button to switch the Target Pointer off.

In case the initial detection of the first K-wire is insufficient (e.g. non-recognition or
display of flickering, green, false-positive lines), it can be helpful to make another
metallic object (e.g. a surgical clamp or another K-wire) visible in the work area.

4.7.5 Pediatric use

The Cios Alpha may be used for pediatric purposes. Use special care when imaging
patients outside the typical adult size range.

The Cios Alpha provides

• a removable anti-scatter grid

• specific pediatric applications

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We suggest using the available special applications for pediatric use in the application
database delivered with the system. There are individual pediatric applications for
each application group of the default application database. These default pediatric
applications may be used for basis of the examination for all pediatric patients (in general
for children up to the age of 14 years).

It is recommended to remove the anti-scatter grid for all pediatric patients up to the age
of 7 years as well as all medical applications that are restricted to extremities.

For pediatric patients older than 7 years a anti-scatter grid is recommended otherwise
image quality may be compromised.
If depending on patient stature the kV increases above 100 kV it is suggested to switch
to the corresponding adult program (otherwise image quality may be compromised).
Depending on the medical needs for your individual examination, consider further dose
saving measures, such as reducing the frames per second as low as possible and reducing
the irradiation time as much as possible.

Following these suggestions will lead to a minimalized dose for the patient.

For an orientation of dose savings please see the following table with a comparison
between pediatric and standard protocols:

Object: 10 cm PMMA directly located on the FD cover (without anti-scatter grid for
pediatric programs)

Fluoro Sub

Application (Group) Standard - Dose rate Pediatrics - Dose rate Standard - Dose rate Pediatrics - Dose rate
(mGy/min) (mGy/min) (mGy/min) (mGy/min)

Card 1.4 0.2 1.6 0.4

Gastro 1.4 0.2 1.5 0.2

General 0.8 0.2 1.1 0.2

Ortho 0.8 0.2 1.1 0.2

Uro 0.8 0.2 1.1 0.2

Vascular 0.8 0.2 1.0 0.2

For these existing pediatric applications we recommend to use the following settings
with these groups of pediatric patients.

The age of a pediatric patient is not the only indicator which needs to be considered by
choosing the best x-ray settings for a child. Other factors, such as the patient’s weight,
body size, and physiological and neurological development may be more appropriate
indicators than chronological age.

Recommendations for pediatric patients:

Age Example Recommended settings

Neonate/birth - e.g., 1-2 kg (2.2-4.4 lb) Please use the 2D application with the
1 month low end estimate name “pediatrics” and please use only the
“low dose” preset and no grid.
0-1 year e.g., 1 year old, ∼11
kg (24 lb); recum‐
1-2 year bent length 100 cm
(39.4 in.)

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Age Example Recommended settings

2-6 years e.g., 5 years old, ∼21 kg Please use the 2D application with the
(46 lb); 113 cm (44.5 name “pediatrics” and please use only the
in) standing height “medium dose” preset and no grid.

7-16 years e.g., 12 years old, Please use the 2D application with the
∼52 kg (115 lb); 156 name “pediatrics” and please use only the
cm (61.5 in) stand‐ “medium dose” preset with a grid.
ing height

16+ years and ∼80 kg (176 lb); stand‐ Please use the normal “adult” programs
adults ing height 170 cm for all acquisition types.
(67.0 in)

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5 Postprocessing
5.1 Patient data 165
5.1.1 When to use the Patient list 165
5.1.2 External data 165
5.1.3 Searching for and selecting patient data 165
Flag 166
Opening the Patient list 167
Sorting data 167
Filtering data 167
Selecting data 168
5.1.4 Correcting data 168
Opening the correction dialog 169
Data Entry Dialog window 169
Editing data 169
5.1.5 Deleting data 170
Deleting data manually 170
Protecting data from deletion 171
5.1.6 Importing data 171
Import dialog 172
Opening the import dialog 172
Data from removable devices 172
Data in the network 173
5.2 2D image processing 175
5.2.1 Loading and displaying images 176
Loading images 176
Displaying the image overview 176
Changing the display mode 177
Scrolling 178
Displaying full screen image 179
Reviewing a scene 179
5.2.2 Selecting images 180
Single selection 180
Multiselection 181
5.2.3 Deleting individual images/series 182
5.2.4 Changing the image display 183
Selecting images for processing 183
Windowing images 183
Inverting images 185
Using image filters 186
Rotating/flipping images 186
Rotating/flipping images in enlarged preview 187
Zooming and panning images 188
Zooming/panning an image in enlarged preview 189
Setting digital shutters 189
Resetting the image display 190
5.2.5 Evaluating images 191
Selecting images for evaluation 191
Displaying the evaluation functions 191
General work steps 192
Calibration 193
Measuring the distance 194
Measuring an angle 195

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Annotating images 196

Setting the side identification 197
5.2.6 Evaluation in enhanced mouse mode 198
Activating enhanced mouse mode 198
Turning off enhanced mouse mode 198
General work steps 198
Calibration 199
Measuring the distance 199
Measuring an angle 200
Annotating images 200
5.2.7 Saving images 202
Saving a single image 202
Saving multiple images 202
5.3 Subtraction processing 202
5.3.1 Postprocessing functions 203
5.3.2 Loading and displaying images 203
Loading images 203
Changing the monitor layout 203
Displaying images 204
5.3.3 Changing the image display 204
Windowing images 204
Including anatomical background (Landmark) 204
Making the image and mask coincide exactly (Pixel shift) 205
5.3.4 Evaluating subtraction images 206
Stenosis quantification 206

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5.1 Patient data

All acquisitions (images, series) prepared as part of an examination are saved in a study
on the hard drive of the imaging system (local database). You can access these data
quickly and easily using the Patient list.

5.1.1 When to use the Patient list

• To examine a patient who has already been examined once before with your
system and whose data are still saved in the local database ( Page 119 Registering
previous patients)

• To view the images of a patient from earlier examinations in order to compare them
with current results

• To postprocess or add comments to images after an examination

• To correct incorrect information on a patient stored in your system

• To print a patient's images for documentation purposes

• To archive patient data and images or to send them to another location in your hospital
via the network

5.1.2 External data

To view or process data from an external storage medium or other network node, they
first have to be imported.

5.1.3 Searching for and selecting patient data

The studies of patients examined previously that are saved to the local database are
displayed in the Patient list.

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(1) Table heading

(2) Study entries (List of patients and their studies)
(3) Preview images of the selected study

Flag
An abbreviation in the Flag column indicates the study status:

Flag Meaning

A/a All/some images were sent to the archive and the receipt
was confirmed (as long as the archive works with DICOM Stor‐
age Commitment)

C Study is closed (no further acquisition possible)

D/d All/some images were transferred to or from CD/DVD

P/p All/some images were printed

R/r All/some images read in via network

S/s All/some images were sent and the receipt was confirmed (if the
recipient works with DICOM Storage Commitment)

# Study is protected against deletion

* Study was received from HIS/RIS

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Opening the Patient list

You open the Patient list on the control panel in the PREPARATION task card.

1 Change to the PREPARATION task card if necessary.

2 Press this button.

The control panel switches to keyboard mode.

The Patient list opens on the left monitor.

Sorting data
You can sort list entries according to the displayed columns.

1 Click the table header for the respective column.

The list is sorted in alphanumerically ascending order based on this column.

Studies with the same entry in the sorting column are further sorted by the date and
time of the examination.

2 Click the table header of the same column again.

The sorting sequence is reversed.

Filtering data
It is possible to only display studies that meet specific criteria by using database filters.
The Flags of the individual studies are evaluated in this case ( Page 165 Searching for
and selecting patient data).

Activating a filter
1 Press this button in the symbol button bar on the control panel.

The Database Filter window appears on the left monitor.

2 Activate the required check boxes.

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show: only display studies with the selected flag

hide: hide all studies with the selected flag

3 Confirm with OK to apply the filter.

You can specifically delimit the list display by combining multiple filter criteria.
Example: Printed and Archived together with hide shows the studies that have
neither been printed nor archived.

Deactivating the filter

1 Press this button in the symbol button bar on the control panel.

The Database Filter window appears on the left monitor.

2 Click this button.

All data (unfiltered) are displayed in the Patient list.

Selecting data
Searching by the first letter 1 Using the keyboard in the control panel, press the first letter of the required patient.

The first name with a suitable patient name is selected in the Patient list.

2 Press this same letter button again, to select the next list entry for a patient with this
first letter.

This approach requires that “Last name” has been set as 1st position in the Name-
display format dialog box.

( Page 237 Name-display format)

Direct selection

◆ Use the arrow buttons on the control panel to select the required study.

– or –

Click the list entry with the mouse.

5.1.4 Correcting data

Every now and then it is necessary to correct patient data for an examination. This is
the case particularly with emergency patients that are saved to the local database with
provisional data.

Patient data in studies you have already exported or sent via the network cannot be
changed in the local database.

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Opening the correction dialog

Patient and examination data are corrected in the Data Entry Dialog window.

1 Select the study entry to be corrected in the Patient list.

2 Press this button in the symbol button bar on the control panel.

The data of the selected patient are transferred to the Data Entry Dialog window.

Data Entry Dialog window

Patient and examination data of the selected study saved in the local database are
entered in the Data Entry Dialog window.

Editing data
Which fields are displayed and therefore can be corrected depends on the configuration
settings ( Page 236 Patient registration).

Changing fields

◆ Use the Tab button (hold down the Shift button to go backwards) or click the mouse
to switch to the required field.

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Correcting the entry

1 On the control panel press the arrow button of the text field to move the
cursor character-by-character.

2 Press this button to delete the character in front of the cursor.

– or –

Mark the incorrect characters with the arrow buttons while holding the Shift button,
and overwrite with the keyboard.

Saving changes

◆ Press this button on the control panel or click the button on the screen to
confirm changes.

The Data Entry Dialog window closes.

The Patient list is updated based on the changes.

5.1.5 Deleting data

You should delete archived images you no longer need from the local database on a
regular basis. This ensures sufficient storage capacity on your system.

You can delete data as follows:

• Automatic deletion

Depending on the configuration settings, images are deleted once they reach a
specific status ( Page 246 Deleting images automatically)

• Manual deletion
You can individually select studies and delete regardless of data status

Deleting data manually

1 Select the entry to be deleted in the Patient list.

2 Make sure that the selected study has been archived correctly.

3 Press this button in the symbol button bar on the control panel.

The selected study and all its images are deleted.

During image postprocessing, you can delete individual images or series of a study
using the image overview ( Page 182 Deleting individual images/series).

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Protecting data from deletion

You can protect images on the local database against unintentional manual deletion and
automatic deletion.

Setting deletion protection

1 In the Patient list select the entry you want to protect against deletion.

2 Press this button in the symbol button bar on the control panel.

Removing deletion protection

1 Select the deletion-protected entry in the Patient list.

2 Press this button in the symbol button bar on the control panel.

5.1.6 Importing data

If the required patient data and images are on removable devices or other network
nodes, import them to the local database. The data are then available in the Patient list.

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Import dialog

(1) Data source selection

(2) Display thumbnails (CD/DVD and USB storage media only)
(3) Disk space required on the hard drive (CD/DVD and USB storage media only)
(4) Button bar
Import: Starts data import
Status: Displays the data transfer status
Close: Closes the dialog window

Opening the import dialog

◆ Click this button on the left monitor (lower left).

The Import from... dialog window is displayed.

Data from removable devices

Image data on a data medium in DICOM format can be read in as long as an appropriate
drive is installed and configured.

Displaying saved data 1 Have the required data medium on hand.

Insert the CD/DVD into the drive.

Connect the USB memory to the USB socket.

2 Select the applicable data medium as the data source in the Import from...
dialog window.

The studies saved on the data medium are listed.

If activated, thumbnails are displayed for the currently selected study.

Example: Displaying the content of a CD/DVD

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Importing data 1 Click the required study with the mouse.

Press and hold the Ctrl button to select multiple entries.

2 Click this button in the Import from... dialog window.

The data are read in.

SR dose reports can not be imported. If a study contains a dose report, the warning
message “Some images could not be transferred” is displayed upon completion of the
import process. However, the study (without the dose report) is imported into the
system and available in the patient list.

Data in the network

You can access image data on other workstations or a long-term archive using “Query
& Retrieve”.

Opening “Query & Retrieve” ◆ In the Import from... dialog window select the DICOM node entry as the
data source.

The Query for retrieve dialog window is displayed.

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(1) Input fields for search criteria (search screen)

(2) Network node selection (data source)
(3) List of search results

Starting a search 1 As search criteria enter the known patient data and further search details,
if necessary.

2 Select the network node where you want to search for the data.

3 Click this button.

The patients and studies found are listed in the results area.

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(1) Details on the study currently selected in the results list

(2) List of found patients and studies
(3) Currently selected study

Displaying series If you only require a selection of images from a specific study, then display the series
contained in the study.
1 Select the corresponding study in the results list.

2 Click this button.

All series of the selected study are listed in the results area.

Use this button to display the list of found patients and studies again.

Importing data 1 Select the required data (studies or series) in the results list with the mouse.

Press and hold the Ctrl button to select multiple entries.

2 Click this button in the Import from... dialog window.

The data are read in.

5.2 2D image processing

As part of postprocessing, you view the results of an examination and evaluate them
using 2D processing functions. You can also compare the image material from various
examinations of a patient (such as the current examination and a previous examination).

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5.2.1 Loading and displaying images

During an examination in progress you can only edit images of the registered patient.
Outside of an examination, you can load the images of any patient for processing.

Loading images
In the Patient list you have access to the images of prior examinations stored on the local
database. Select one or more studies of the required patient here ( Page 165 Searching
for and selecting patient data).

With an examination in progress, all saved images are already loaded. If needed, you can
load additional images from prior examinations of the registered patient.

If the required images are no longer in the local database, then first import the data
from the external source ( Page 171 Importing data).

1 Change to the PREPARATION task card if necessary.

2 Open the Patient list.

3 Search for the patient, sorting and filtering the list as necessary.

4 Select the required study or studies.

5 Press this button in the symbol button bar on the control panel.

The selected images are loaded and displayed on the monitors.

The PROCESSING task card is displayed on the control panel.

– or –

Double-click the patient with the mouse.

Displaying the image overview

In the image overview display, the monitor layout changes specifically for 2D-
postprocessing. You have direct access to all loaded images and you can select them for
processing either individually or in any combination.

Activating the overview If a patient is not registered the images are displayed in the image overview after loading.
With an examination in progress, you may need to switch from the live image display to
the image overview display.
◆ Press this button on the control panel.

– or –

On the left monitor click the 4x4 layout button (lower left).

The Overview menu is displayed on the control panel.

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(1) Selection buttons for Series/Images

(2) Full image display
(3) Multi-selection of Series/Images
(4) Display mode (Stack/Stripe)

Monitor layout The following views are set on the monitors by default:

• Left monitor

– 4x4 layout with all loaded images, sorted by exposure time

– Stack display

– 1st series selected (1st image segment is highlighted)

• Right monitor

– 1x1 display of the (selected) 1st series

Switching off the overview The image overview can only be switched off during an examination in progress.

◆ Press this button again.

The live image display is activated.

– or –

On the left monitor click the activated 4x4 layout button (lower left).

The system switches to live image display automatically during radiation release.

Changing the display mode

You can select from among the following displays of loaded images on the left monitor:

• Stack display: One series per image segment

• Image stripe display: One image from the selected series per image segment

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Selecting stack display Stack display is suitable as an overview of loaded studies and for direct comparison of
images from several series.
◆ Press this button in the Overview menu.

Selecting image stripe display Image stripe display is suitable for viewing a selected series in detail (image by image).

◆ Press this button in the Overview menu.

In stack display, image segments that contain a scene are identified by an icon at the
bottom right. Double-clicking the scene switches to image stripe display.

Scrolling
In the Overview menu you establish which image should be displayed on the
right monitor.

Changing image/series

1 Select the suitable display mode:

Image stripe display if you want to show a different image in the current series.

Stack display if you want to display a different series.

2 Scroll in the image overview until the number of the required image or series
is displayed.

3 Press the selection button for the required image or series.

The selected image is displayed on the right monitor.

– or –

In the left monitor click the applicable image segment with the mouse.

Next/Previous series If you want to show images of another series in image stripe display, you can scroll
through the series without switching to stack display.

◆ Press one of the buttons repeatedly if necessary.

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Displaying full screen image

Basically, the image selected in the overview is displayed as a full image on the right
monitor. However, if the Hold reference function is active the monitor display remains
unchanged. In this case use the Full image function to display the required image in full
size on the left monitor.

Activating full image

◆ Press this button in the Overview menu.

Using the Next/Previous series buttons you can switch to other series in full
image view.

Switching off full image

◆ Press this button again.

The image overview on the left monitor switches into the most recent display mode
(stripe or stack).

Outside of an ongoing examination (no patient registered), you can turn full image
view on and off using the activated 4x4 layout button (lower left of screen).

Reviewing a scene
After an examination, you can start movie mode to check the quality of the scenes
you acquired.

A scene is usually reviewed on the right monitor. If Hold reference is active, the review
takes place on the left monitor. The system switches automatically to 1x1 layout.

Cine replay menu 1 Show the required scene.

2 Press this button.

The Cine replay menu appears.

Starting the review If the automatic review of scenes (Auto replay) is switched off, the review process
is paused.
1 Press the activated Pause button to review the scene.

The replay speed varies with the number of saved images.

During review the Pause button changes to a Play button.

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2 Press this button to change the review speed.

Replay at half/normal/double speed.

Limiting the playback range 1 Switch to the required image, for example using the slider or by stopping the review
process at the appropriate location.
2 Press one of the buttons to set the starting point or end point for playback.

The corresponding image number is displayed in the respective button.

By pressing the starting point and end point buttons again you can reset the original
playback range.

Scrolling image by image

1 Press this button to stop the review process.

2 Press the button to go backward/forward by a single image.

Different scene

◆ Press the button for the previous/next available scene.

5.2.2 Selecting images

You have to select images before you edit them. Single and multiple selections
are possible.

◆ Select the suitable display mode in the Overview menu:

Image stripe display if you want to select multiple images in the current series.

Stack display if you want to select one or more series.

Single selection
◆ Press the selection button for the required image or series in the Overview menu.

– or –

In the left monitor click the applicable image segment with the mouse.

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If the left monitor has been changed to full image mode, the image displayed there
is selected.

Multiselection
Multiselection enables you to select images from one or more series individually. Images
of a multiselection are marked on both monitors by a white dot.
1 Press this button in the Overview menu.

The menu extension for multiselection is shown.

The number of images currently selected is displayed.

2 Pressing the button again toggles to single selection.

Individual images/series

◆ Press the selection buttons for the required image or series in sequence.

– or –

Switch into keyboard mode, hold down the Ctrl button, and click the desired images/
series on the left monitor.

Sequential images/series
1 Press this button.

2 Select the first required image/series.

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3 Select the last required image/series.

All images/series in between are selected as well.

Supplementing the selection

1 Switch the display mode if necessary.

2 Select additional images/series using multiselection.

The newly selected images are added to the multiselection previously defined.

– or –

Press this button to add the image or series selected in the image overview to the
multiple selection.

All images/series

◆ Press this button.

Image stripe display: All images in the series are selected.

Stack display: All loaded images are selected.

Deselecting images

◆ Deselect the selected images/series individually using the corresponding selection

buttons in the image segments.

– or –

Press this button for the images or series to be deselected.

Press this button to deselect all images.

5.2.3 Deleting individual images/series

While the Patient list is used to delete complete studies ( Page 170 Deleting data), you
can use the image overview to select individual images or series for deletion.

1 In this case switch into stack display.

2 Switch into keyboard mode and press Alt + d.

A message box is displayed on the left monitor.

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3 Click the images/series to be deleted in the image overview.

The selected images are marked with an X.

4 Click OK to delete the selected images.

5.2.4 Changing the image display

In the loaded images you can adapt the window values (contrast and brightness), display
enlarged sections, and center regions of interest in the middle of the image. You can also
rotate, flip or invert images for certain diagnostic problems.

Image manipulation capabilities are limited for images imported from other modalities
and images from external video sources (CAP images).

CAUTION

Incorrect or extreme image processing parameters.

Risk of limited image quality in the resulting X-ray images. Risk of incorrect
decision during intervention or artifacts.

◆ Apply image processing parameters carefully, such as edge enhancement and

windowing, and always check them carefully.
◆ Always check the image quality before reaching an interventional decision.

Selecting images for processing

Changes in image display affect all images of an individual series. The image functions
cannot be applied to multiple series at the same time.

◆ Display an image of the required series (single selection).

Windowing images
Using the windowing settings, you establish a grayscale range in which the image
is displayed. This enables you to highlight the region of interest and the relevant
tissue type.

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During windowing you optimize image brightness (shifting the windowing center along
the grayscale) and image contrast (change of window width).

The set window values are shown at the bottom right in the image.

(1) WW: Window width – Contrast

(2) WC: Window center – Brightness

Brightness Contrast menu

◆ Press this button.

The Brightness Contrast menu is displayed.

Changing window values 1 Move the slider to the left/right to make infinitely variable adjustments in brightness
(1) and contrast (2).

2 Click the left/right arrow to change the window values in small increments.

The controllers set numerical brightness values. Whether the image impression turns
out brighter or darker depends on which display is selected (bone black or white).

Changing brightness and

contrast in enlarged preview

1 Open the Brightness Contrast menu of the enlarged preview.

2 Press Help for help on how to drag to change window levels, if required.

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3 Tap the image and drag left or right to change the brightness.

– or –

Drag up or down to change the contrast in the image.

4 Press this button to reset the brightness and contrast values.

Windowing using the mouse 1 Place the mouse pointer in the required image on the left monitor.

2 Move the mouse with the center mouse button pressed:

(1) Contrast - (Center +)

(2) Contrast + (Center -)
(3) Brightness - (Width +)
(4) Brightness + (Width -)

Fixed window value settings Using window value settings, you can select three predefined settings for the window
(LUTs) values using LUTs (look up tables). The values can be configured specifically for an
application ( Page 255 Editing applications).

◆ Press the button for the required preset.

Default The Default setting assigns the window values from auto contrast.

◆ Press this button.

Brightness and contrast are reset to the default.

Inverting images
When an image is inverted, bright areas in grayscale images are displayed dark and dark
areas are displayed bright. You use this function to toggle the bone display between
white and black, for example.

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1 Open the Brightness Contrast menu.

2 Press this button.

Image inversion is switched on.

Using image filters

You can improve the appearance of blurred images using appropriate filters. The
following filters can be used individually or in combination:

• Edge filter

Image enhancement menu

◆ Press this button.

The Image enhancement menu opens.

Selecting the edge filter Edge enhancement is an adaptive filter that highlights all existing structures (edges)
in the image. For very noisy images, setting edge enhancement to its lowest level or
switching it off entirely is recommended.

◆ Press one of these buttons.

The higher the filter setting, the more structures are enhanced and the less they
are smoothed.

– or –

Press this button.

Edges are not enhanced.

Rotating/flipping images
The rotate and flip functions allow you to easily compare images of series that were
acquired in a different orientation.

Rotation Flip menu

◆ Press this button.

The Rotate Flip menu appears.

Selecting the image rotation

◆ Press one of these buttons.

With each short press of the button, image rotation increases 1° in the
corresponding direction.

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Pressing the button for an extended period continually increases or decreases the
angle of rotation.

– or –

Use these buttons to set the angle of rotation in 90° increments.

Rotate using the mouse 1 Place the mouse pointer on the edge of the required image on the left monitor.

2 Drag the mouse pointer in the required direction of rotation.

No image rotation

◆ Press this button.

The angle of rotation is reset to 0°.

Selecting image flip

◆ Press one of these buttons.

Vertical/horizontal image flip is activated.

Rotating/flipping images in enlarged preview

1 Open the Rotate Flip menu of the enlarged preview.

2 Press Help for help on how to drag to rotate and flip the image, if required.

3 To rotate the image, tap a point inside the image area (marked dark grey in the
gesture help image) and drag clockwise or anti-clockwise.
4 Press this button to reset image rotation to 0°.

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5 To flip the image vertically, tap a point close to the left edge of the image area
(marked light grey in the gesture help image) and drag up or down.
6 To flip the image horizontally, tap a point close to the bottom edge of the image area
(marked light grey in the gesture help image) and drag left or right.

Zooming and panning images

You can zoom in on sections of images that you are particularly interested in (zooming).
The zoomed image can be panned so that the relevant section is in the center of the
image (panning).

Zoom Pan Shutter menu

◆ Press this button.

The Zoom Pan Shutter menu appears.

Zooming the image

1 Move the slider up/down for infinitely variable zoom in/zoom out of the image.

Upper limit: Zoom factor 4x

Lower limit: Zoom factor 1x

2 Click the up/down arrow to change the image size in small increments.

Panning the image After zooming, if the relevant image area is outside the image segment, pan
it accordingly.

◆ Press the arrow button for the direction in which the image content to be displayed
is located.

Vertical arrow buttons: Pan up/down

Horizontal arrow buttons: Pan left/right

Diagonal arrow buttons: Combined horizontal and vertical pan

Image panning is possible only with a zoom factor > 1x.

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Resetting Zoom/Pan

◆ Press this button.

The original image display is restored.

Zooming/panning an image in enlarged preview

1 Open the Zoom Pan menu of the enlarged preview.

2 Press Help for help on how to drag to zoom and pan the image, if required.

3 To zoom the image, tap a point close to the edge of the image area (marked light grey
in the gesture help image) and drag up or down.

4 To pan the image, tap a point in the center of the image area (marked dark grey in
the gesture help image) and drag in the required direction.

5 Press this button to reset the zoom value.

Setting digital shutters

You can hide irrelevant areas of the image. To do that, you place appropriate shutters
over the image. Image areas covered by shutters appear black.

1 Open the Zoom Pan Shutter menu.

2 Press this button.

The menu extension for shutter definition is shown.

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Adding shutters You can slide a total of 4 rectangular shutters into the image starting at the edges. First
activate them individually or jointly using the appropriate buttons, and then fit them
into place.
1 Press one of these buttons for the shutters you want to set.

Upper shutter

Right shutter

Left shutter

Lower shutter

2 Press this button to slide the activated shutters toward the center of the image.

3 Press this button to slide the activated shutters toward the edges of the image.

4 Press one of these buttons to rotate the activated shutters left or right.

Hiding the shutters

◆ Press this button.

The full image area displayed again.

Resetting the image display

If adjusting the image parameters did not produce the desired results, you can reset
the processing steps of the current session. All images are then returned to their
original state.

• During an examination in progress: Status after image acquisition or after saving

• Outside an examination: Status after loading or after saving

After resetting, all changes in the image display are irrevocably lost.

1 Press this button.

A confirmation dialog box is displayed.

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2 Press Yes to reset the images.

– or –

Press No to close the dialog box without changes.

5.2.5 Evaluating images

Using graphical evaluation functions you can measure distances, lengths, and angles of
relevant structures, as well as add annotations. The left monitor switches automatically
to 1x1 layout. When the evaluation is finished the original monitor layout is restored.

Measurements are not possible for images imported from other modalities and images
from external video sources (CAP images).

Selecting images for evaluation

Graphical evaluations can only be performed on a single image at a time.

◆ Display the required image (single selection).

Displaying the evaluation functions

The evaluation functions are available on every control panel in the Measure Annotate
menu. If you are working on the monitor trolley, you can switch to enhanced mouse
mode and open the evaluation functions from the screen menu ( Page 198 Evaluation
in enhanced mouse mode).

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Measure Annotate menu

◆ Press this button.

The Measure Annotate menu appears.

General work steps

During graphical evaluation you use graphic objects (such as lines and text fields)
that you draw in the image on the left monitor. The graphic objects are saved in the
image automatically.

The following presents the basic steps you will use with graphic objects regardless of the
evaluation function.

Moving the mouse pointer Use the mouse pointer to set the position in the image where you want processing of
graphic objects to take place (such as insert, select).
◆ Use the arrow buttons to move the mouse pointer in the image.

Vertical arrow buttons: Move up/down

Horizontal arrow buttons: Move left/right

Diagonal arrow buttons: Combined horizontal and vertical movement

– or –

Move the mouse pointer with the mouse.

Selecting You must select an existing graphic object to process it.

◆ Move the mouse pointer with the arrow buttons or the mouse to the graphic object.

Highlighting of the reference points (vertices, center point) indicates that the graphic
object is selected.

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Panning 1 Select the graphic object.

2 Press this button.

The graphic object is linked to the mouse pointer.

3 Move the graphic object to the required position with the arrow buttons or mouse.

4 Press this button.

The link between the graphic object and the mouse pointer is removed.

Deleting (individual) 1 Select the graphic object.

2 Press this button.

The selected graphic object is deleted.

Deleting (all)

◆ Press this button.

All graphic objects in the image are deleted.

Calibration
If you perform evaluations with distance measurements, you must calibrate the image.

Calibration object For increased accuracy it is recommended to use a calibration object that is as large as
possible, but still can be displayed completely. The edges of the calibration object must
be clearly recognizable and its dimensions must be known.

CAUTION

Wrong calibration value is entered, or length or angle information are not

interpreted correctly.

Insufficient or incorrect basis for diagnostic or therapeutic decisions!

◆ Note that the measuring results of the functions “Distance” and “Angle” depend
on various factors, e. g., the position of the calibration object. Note that the
acquired images represent two-dimensional projections of real objects. Verify
the results before diagnostic or therapeutic decisions are taken.

Please note that the calibrating accuracy decreases if the calibration object is not
located in the same plane as the measured object.

Performing calibration

1 Draw a distance line along the calibration object.

Be careful to mark the starting and end points with as close to pixel accuracy as
possible in order to achieve optimal measuring accuracy (the line to be calibrated has
to be selected/marked).

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2 Then press this button.

The control panel switches to keyboard mode.

3 Enter the distance (in mm) and confirm with Enter.

A length scale is displayed in the image and is applied to the remaining images of
the series.

Distances already drawn in are updated.

Measuring the distance

Using a distance line, you can measure the distance between two points in an image.
Proceed carefully when setting the starting and end points in order to be as accurate
as possible.

Ideal conditions for distance measurement are as follows:

• Object lying directly on the detector

• The reference points have the maximum possible distance in the image, i.e. an
accordingly large reference object was used

• The measures of the reference object are known with a high accuracy (less than
0.1 mm)

• Reference points and measurement points are exactly in the reference plane

• User defines reference line and measurement line with an accuracy of one image
element (pixel)

In reality, these conditions are usually not fulfilled.

The measurement results depend (among others) on following factors of influence:

• Reference calibration and distance measurement need to be performed in the

same plane (as close as possible) and this plane needs to be parallel to the
detector’s plane.

• The measurement accuracy amounts to 5% under the following conditions: The

reference object is at least 50 mm large, and its size is known at ±1 mm accuracy.
The actual inclination between the measurement and the detector plane must not
exceed 5°. The plane of the object to be measured must be located within max. 1cm
from that of the reference object, and it should not have a distance of less than
"(SID /2) - 10cm" from the X-ray tube.

• Furthermore, there are influences emerging from the recongizability of the

objects themselves and from the user’s accuracy of recording the objects on
the screen. Large and exactly bordered reference objects featuring high contrasts
are recommended. The user is responsible for keeping these impacts as small
as possible.

Distance drawing mode

◆ Press this button to activate the Distance drawing mode.

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Setting the starting point

◆ Use the arrow buttons to move the mouse pointer to the starting point of the line and
press this button.

– or –

Click the starting point with the left mouse button.

The starting point of the line is set.

The button changes to Set last point.

Setting the last point

◆ Use the arrow buttons to move the mouse pointer to the last point of the line and
press this button.

– or –

Click the last point with the left mouse button.

The distance line is set.

The length (in mm) and the sequential number of the graphic object are displayed at
the end point of the line.

The accuracy of a length measurement depends on user interactions and cannot be

specified here absolutely. See also the info box above.

Deleting points If the starting point or end point has been placed incorrectly, it can be deleted
immediately after being drawn.

◆ Press this button.

The last point set is deleted from the image.

Pressing the button again deletes the starting point if available.

You can continue drawing the line.

Measuring an angle
You can define an angle by two lines, the legs of the angle that you draw on the image.
Proceed carefully when setting the starting and end points in order to obtain as high an
accuracy as possible.

Ideal conditions for angle measurement are as follows:

• Object lying directly on the detector

• The points defining the angles have the maximum possible distance in the image

• User defines reference line and measurement line with an accuracy of one image
element (pixel)

• Reference points and measurement points are exactly in the reference plane
In reality, these conditions are usually not fulfilled.

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The results of the angular measurements depend (among others) on the following
influencing factors:

• The angular measurement is performed in a projection plane parallel to the

detector’s plane only. The measurement accuracy in this projection plane amounts
to ±1°, if the length of the drawn angle legs is at least ¼ of the image width.

• Furthermore, there are influences emerging from the user’s accuracy of recording
the objects on the screen. It is recommended to draw angles with legs which are
as long as possible. The user is responsible for keeping these impacts as small
as possible

Angle drawing mode

◆ Press this button to activate the Angle drawing mode.

Drawing an angle

1 Draw the first line in the image by setting the starting point and end point
( Page 194 Measuring the distance).

The first leg of the angle is set.

2 Draw the next line in the image by setting the starting point and end point
( Page 194 Measuring the distance).

The angle is set.

The drawn angle (in °) and the sequential number of the graphic object are displayed
at the end points of the legs.

Either an inner or outer angle is indicated depending on the starting point and end
point of the second leg.

The accuracy of angle measurement depends on user interactions and cannot be

specified here absolutely. See also the info box above.

The accuracy can be improved by increasing the distances between the starting and
end points of the legs drawn in.

Annotating images
You can annotate interesting or anomalous areas in the image accordingly.

Text drawing mode

1 Press this button to activate the Text drawing mode.

2 Move the mouse pointer to the required position for the annotation with the arrow
buttons or mouse.

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Entering text

1 Press this button.

The control panel switches to keyboard mode.

2 Enter the text and confirm with Enter.

The text is inserted at the position of the mouse pointer.

Inserting predefined text Frequently used texts can simply be selected from a template once they have been
created as such ( Page 200 Annotating images).

◆ Select the required text from the selection list.

The text is inserted at the position of the mouse pointer.

Changing text 1 Select the graphic object with the text.

2 Press this button to change the text using the keyboard.

– or –

Select a new text from the selection list.

Setting the side identification

By identifying the side of the patient you avoid a mistake in image orientation. The side
identification is applied automatically to the remaining images of the series.
◆ Switch on the Text drawing mode, if required.

Adding side identification 1 Move the mouse pointer to the required position for the identification (such as the
edge of the image) with the arrow buttons or mouse.

2 Press the button for the correct patient side.

The selected identification L or R is inserted at the position of the mouse pointer.

Changing the
side identification

◆ Press the button for the correct patient side.

The original side identification is deleted.

The selected identification L or R is inserted at the position of the mouse pointer.

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5.2.6 Evaluation in enhanced mouse mode

When you evaluate images on the monitor trolley you can perform all evaluation
functions directly on the left screen with the mouse. You only use the control panel to
enter text.

Activating enhanced mouse mode

1 Click this button on the left monitor (lower left).

The buttons for evaluation with the mouse are displayed (upper left).

2 Click the button for the required function.

Enhanced mouse mode is activated.

The control panel switches to keyboard mode.

Turning off enhanced mouse mode

◆ Click the button of the activated function.
– or –

End keyboard mode.

General work steps

During graphical evaluation you use graphic objects (such as lines and text fields)
that you draw in the image on the left monitor. The graphic objects are saved in the
image automatically.

The following presents the basic steps you will use with graphic objects regardless of the
evaluation function.

Selecting You must select an existing graphic object to process it.

1 Click this button.

The "Selection" function is activated.

2 Click the graphic object.

Highlighting of the reference points (vertices, center point) indicates that the graphic
object is selected.

Panning 1 Select the graphic object.

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2 Press the mouse button and drag & drop the center point to the required position.

Changing dimensions 1 Select the graphic object.

2 Press the mouse button and drag & drop the vertices in the required direction.

Deleting (all)

◆ Click this button on the left monitor.

All graphic objects in the image are deleted.

Deleting (individual) 1 Select the graphic object.

2 Press this button on the control panel.

The selected graphic object is deleted.

Calibration
1 Draw a distance line along the calibration object and select it ( Page 199 Measuring
the distance).

Be careful to mark the starting and end points with as close to pixel accuracy as
possible in order to achieve optimal measuring accuracy.

2 Then click this button.

The Calibrate dialog box is displayed.

3 Enter the distance in arbitrary units (e.g., in mm).

4 Click OK.

A length scale is displayed in the image and is applied to the remaining images of
the series.

Distances already drawn in are updated.

Measuring the distance

Using a distance line, you can measure the distance between two points in an image.
Proceed carefully when setting the starting and end points in order to obtain as high an
accuracy as possible.

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1 Click this button.

2 Click the starting point of the line.

3 Click the desired end point.

The distance line is set.

The length (in units as used for setting the reference distance) and the sequential
number of the graphic object are displayed at the end point of the line.

The accuracy of a length measurement depends on user interactions and cannot be

specified here absolutely. See also the info box in section ( Page 194 Measuring
the distance).

Measuring an angle
You can define an angle by two lines, the legs of the angle that you draw on the image.
Proceed carefully when setting the starting and end points in order to obtain as high an
accuracy as possible.

1 Click this button.

2 Draw the first line in the image by setting the starting point and end point.
The first leg of the angle is set.

3 Draw the next line in the image by setting the starting point and end point.
The angle is set.

The drawn angle (in °) and the sequential number of the graphic object are displayed
at the end points of the legs.

Either an inner or outer angle is indicated depending on the starting point and end
point of the second leg.

The accuracy of angle measurement depends on user interactions and cannot be

specified here absolutely. See also the info box in section ( Page 195 Measuring
an angle).

The accuracy can be improved by increasing the distances between the starting and
end points of the legs drawn in.

Annotating images
In addition to side identification and annotating interesting or anomalous areas in an
image, you can add image comments. Comments always appear centered at the bottom
edge of the image and are transferred automatically to all images of the series.

◆ Click this button.

The input dialog box for text and comments is displayed.

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Setting the side identification By identifying the side of the patient you avoid a mistake in image orientation. The side
identification is applied automatically to the remaining images of the series.

1 Select the appropriate patient side in the text and comments dialog box.

2 Using the mouse, click the appropriate location in the image (e.g. at the edge of
the image).

The selected identification L or R is inserted at the position of the mouse pointer.

Inserting annotations 1 Select the annotation from the Text selection list.

– or –

Click the text field of the Text selection list and overwrite the displayed text with
the keyboard.
2 Click the required position in the image.

Adding a comment ◆ Select the text from the Comment selection list.

– or –

Click the text field of the Comment selection list and overwrite the displayed text with
the keyboard.

To delete a comment from the images, use the Backspace button to delete it from the
text field of the Comment selection list.

Creating predefined texts You can save frequently used texts and comments as templates and select them from the
list as needed.

1 Enter the text in the text field of the corresponding selection list.

2 Click this button.

The text is added to the list as a new entry.

Up to 20 entries each can be created in the Text and Comment selection lists.

Deleting predefined texts 1 Select the entry you no longer require from the corresponding selection list.

2 Click this button.

The text is deleted from the list.

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5.2.7 Saving images

After completing postprocessing of a prior examination, all changes in the image are
saved when you close the patient. If you want to save intermediate states, manually
save the images in the required processing phase. The images are saved as copies of the
original in the corresponding study.

To save images while an examination is in progress see ( Page 143 Saving and
displaying images).

Saving a single image

✓ Multiple images are not selected ( Page 181 Multiselection).

1 Display the required image (single selection).

2 Press this button.

Saving multiple images

With the appropriate image selection you can save a portion or all images of one or more
series, as well as segments of series.

Images/series 1 Select the required images/series in multiselection ( Page 181 Multiselection).

2 Press this button.

Partial scene 1 Show the scene.

2 Open the Cine replay menu.

3 Limit the replay range of the scene to the relevant section.

4 Press this button.

The images are saved from the starting point to the end point as a new scene.

5.3 Subtraction processing

When subtraction is performed, two X-ray exposures are acquired of the region of
interest, one without contrast agent and one with contrast agent. Afterwards both
exposures are subtracted.

In the subtraction image, areas with the same attenuation and areas with a (slightly)
different attenuation, e.g. vessels with contrast agent, can be discerned clearly.

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5.3.1 Postprocessing functions

The following functions are available to postprocess subtraction images during or after
an examination:

• Anatomical background

• Pixel shift

• Stenosis quantification

5.3.2 Loading and displaying images

Native images from examinations acquired in Subtraction or Roadmap operating mode
(optional) are stored in the local database together with the subtraction images. Both
image types can be displayed simultaneously on both monitors.

Loading images
With an examination in progress, the images required for subtraction processing are
already loaded and saved. For subsequent processing, load the subtraction data from the
local database.

1 Select the subtraction study of the required patient in the Patient list.

2 Press this button in the symbol button bar on the control panel.

The selected images are loaded and displayed on the monitors.

The PROCESSING task card is displayed on the control panel.

Changing the monitor layout

After loading the images, 2-channel display is activated with both monitors in 1x1 layout.
The left screen shows the subtraction images, the right screen the corresponding native
images. This setting can be switched if necessary.

1 Press this button.

The Sub / Native menu appears.

2 Select the required monitor layout.

2-channel display (only for full image display on the left monitor). Simultaneous display
of the subtraction image (left monitor) and corresponding native image (right monitor).

1-channel display – native images. Only native images are shown on both monitors.
Applies particularly when the image overview is activated on the left monitor.

1-channel display – subtraction images. Only subtraction images are shown on both
monitors. Applies particularly when the image overview is activated on the left monitor.

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Displaying images
After switching the monitor to 1-channel display, use the image overview display to show
the required images.

1 Switch on image overview if necessary.

2 Use the functions for image display in the same manner as for standard examinations
(without subtraction).

• Changing the display mode ( Page 177 Changing the display mode)

• Scrolling ( Page 178 Scrolling)

In stack display the maximum fill image (Peak OP image) of the respective series
is displayed.

• Reviewing a scene ( Page 179 Reviewing a scene)

In 2-channel display, the subtraction scene plays on the left monitor, the
corresponding native scene simultaneously on the right monitor.

5.3.3 Changing the image display

As with standard examinations (without subtraction) you can window, zoom/pan,
rotate, and flip subtraction and native images ( Page 183 Changing the image display).

The following presents special functions for use exclusively with subtraction data sets.

Windowing images
The change in windowing settings always refers to an image type. In 2-channel display
you select whether you want to window subtraction images or native images.

1 Open the Brightness Contrast menu.

2 Press the button for the required image type.

3 Change the window value settings using the functions in the Brightness
Contrast menu.

– or –

Press the button for automatic window value assignment.

If available, window values are adjusted based on the maximum fill image.

Including anatomical background (Landmark)

Normally the anatomical surroundings of vessels of interest are not visible in images
that are displayed subtracted. By adding the mask image, the surrounding tissue can be
highlighted more or less.

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1 Press this button.

The Pixel shift Landmark menu appears.

2 Set the degree of inclusion with the slide control.

0%: Fully subtracted (without anatomical background)

100%: Native display

Making the image and mask coincide exactly (Pixel shift)

During acquisition of the subtraction series, the patient or the C-arm system may have
moved. The images that are to be subtracted may not be congruent. The anatomical
background, especially in the area of image contrasts, is therefore not canceled out.

Through a suitable shift of the mask by a few pixels, you eliminate the displacement of
fill image and mask. Applying a pixel shift will also have an effect on the representation
of the fill image.

The image shift with pixel shift is used in forward direction for subtraction scenes; that
is, for subsequent images, not backward for previous images.

You can use manual and auto pixel shift multiple times one after the other or in
combination as soon as the previously changed pixel shift is accepted.

Pixel shift Landmark menu 1 Display the required subtraction series (single selection).

2 Press this button.

The Pixel shift Landmark menu appears.

The subtraction series is shown in image stripe display on the left monitor.

The currently selected image of the subtraction series is shown on the right monitor.

Selecting the image ◆ Use the slider to display the first image with poor coverage on the right monitor.

Automatic pixel shift Mark an area of obvious displacement in the subtraction image. The pixel shift needed
for alignment is calculated automatically.

1 Press this button to switch from manual pixel shift (default) to auto pixel shift.

In the preview image on the right monitor, a rectangle indicates the mouse position
in the center of the image.

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2 Move the rectangle to the position in the image where misalignment is most evident.

3 Press this button to apply the pixel shift to the current and subsequent images.

Manual pixel shift Shift the mask manually until the best impression of the subtraction image is achieved.

1 Press this button to switch from auto pixel shift to manual pixel shift, if necessary.

2 Move the mask with the arrow buttons until you get optimum coverage.

3 Press this button to apply the pixel shift to the current and subsequent images.

Peak-OP preview Peak-OP preview allows checking the modified pixel shift before the new value is saved
using Accept pixel shift.
◆ Press this button to calculate a Peak-OP image based on the current pixel
shift settings.

The new Peak-OP image is displayed on the right monitor.

Undoing pixel shift Accept pixel shift applies the changed pixel shift to the affected images and saves it. In
the event of an error, you can cancel the last step or all steps.

◆ Press this button to cancel the last change in the pixel shift.

– or –

Press this button to restore the state prior to opening the Pixel shift Landmark menu.

5.3.4 Evaluating subtraction images

The following presents special evaluation functions for subtraction data sets.

Stenosis quantification
In stenosis quantification, the reduction of vascular diameter is determined through a
stenosis identified in the image.

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Stenosis measurements should preferably be done using subtracted images. The

edge position has to be checked in native display or with anatomical background. If
necessary, the vascular edges have to be corrected manually.

Opening 1 Display the desired fill image (single selection).

stenosis quantification
2 Click this button on the left monitor (lower left).

The control panel switches to keyboard mode.

The Stenosis Quantification dialog box is displayed.

Defining the vascular course You identify the vascular course by drawing the center line of the vessel as a polygon.
With each change of direction, you set a vertex in the image. The center line of the vessel
should include the section with the pathological (stenotic area) and normal vascular
diameter (reference area).
1 You set the starting point and vertices with a single click of the mouse.

A line is drawn connecting the points.

2 Set the end point with a double click of the mouse.

A vascular contour is determined and drawn in the image.

Stenosis calculation

After drawing the vascular contour, the "stenosis diameter" (white line) and "reference
diameter" (gray line) are determined automatically, and each is displayed as a bar cursor.

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The degree of stenosis relative to the reference area is output in %:

• %D: (D = diameter) deviation of the diameter on line "Stenosis diameter"

as a percentage relative to the diameter on the line "Reference diameter" (1-
Dsten/Dref)*100%

• %A: (A = area) deviation of the calculated area of the circle as a percentage (¼*π*D2)
on the "Stenosis diameter" line, relative to the calculated area of the circle on the
"Reference diameter" line (1-Asten/Aref)*100%

• %G: (G = gray level) deviation of the gray level on the "Stenosis diameter" line
as a percentage relative to the gray level on the "Reference diameter" line (1-
Gsten/Gref)*100%

Please note:

• Values are limited to ± 100%

• Negative values are an indication that the lines for stenosis diameter and reference
diameter are incorrectly assigned.

The results of the stenosis quantification tool highly depends on the image content.
So the results are influenced by the body anatomy (thickness and vessel form
and routing), the projection (angle, distance to focus, etc.), the achieved image
contrast (dose), the contrast medium and many other factors.The displayed values
from the stenosis quantification tool always need to be checked for plausibility.
This can be achieved by Subtraction images from a different projection angle and
additional indicators like (EEG, ECC). Under laboratory conditions, when using images
of calibrated phantoms with known diameters, the tolerance for the stenosis diameter
measurement comparison is 10% or less. Grayscale proportions are a percentage
of integrated grayscale values and give a hint to none circular stenosis but do not
represent a geometric measurement value.

With non-circular stenoses, the stenosis may only be recognizable by the gray level ratio:

Example: Ves‐ Possible display in Result of steno‐

sel cross-sec‐ X-ray image (sche‐ sis quantification
tion (schematic) matic)

Vessel circular No stenosis found

(no stenosis) for diameter, area,
gray level

Non-circular steno‐ Stenosis only found

sis for gray level

Moving the stenosis/reference The positions of the stenosis and reference cursors can be changed individually. The
cursor stenosis is then recalculated automatically.

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1 Drag the slider to the desired position or click the arrow buttons.

– or –

Press these buttons on the control panel to move the stenosis cursor.

2 Press these buttons on the control panel to move the reference cursor.

Correcting contour lines You change the course of the contour line by manually redrawing the vascular edge
in the section to be corrected. The stenosis is then recalculated automatically after
the correction.

1 Mark the starting point of the vascular contour to be corrected with a click of
the mouse.

If the mouse pointer is located over a valid vascular position, it takes the shape of
a cross.
2 Mark the end point of the vascular contour to be corrected by double clicking.

The vascular contour between these points is changed.

Moving the stenosis text block After the stenosis is drawn in the image, you can move the text block to another position,
for example, if it is covering an important detail.
◆ Click the text block; drag the text block to the new position, and click again at the
new position.

A number indicates the stenosis cursor to which the text block belongs.

Confirming ◆ Click OK in the Stenosis Quantification dialog box.

stenosis quantification

If necessary you can evaluate additional stenoses in the image in the same manner.

Deleting stenosis 1 Click the stenosis to be deleted.

calculation (individual)
The stenosis is marked by small squares.

2 Click this button in the Stenosis Quantification dialog box.

The selected stenosis graphic with evaluation is deleted.

Other stenosis graphics are retained.

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Saving the stenosis image

◆ Click this button in the Stenosis Quantification dialog box.

The stenosis graphics are “burned into” the image.

The image is stored as a new image and is assigned to the study.

The results of the stenosis quantification tool highly depends on the image content.
So the results are influenced by the body anatomy (thickness and vessel form and
routing), the projection (angle, distance to focus, etc.), the achieved image contrast
(dose), the contrast medium and many other factors.

The displayed values from the stenosis tool always need to be checked for plausibility.
This can be achieved by Subtraction images from a different projection angle and
additional indicators like (EEG, ECC).

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6 Documentation
6.1 Filming/Printing 212
6.1.1 Selecting images 212
Single image 212
Multiselection 213
6.1.2 Printing using default settings 213
Starting printing 213
6.1.3 Printing with changed settings 214
Input dialog box for print settings 214
Changing print settings 214
Displaying a print preview 215
Starting printing 215
6.2 Exporting 216
6.2.1 Export procedures 216
Standard export 216
Changing the export settings 216
Automatic export 216
6.2.2 Export destinations 216
Removable device 217
Other workstation 217
Archive 217
6.2.3 Overview of transfer capabilities 218
6.2.4 Selecting images 219
Images from an examination in progress or postprocessing 220
Complete studies 220
6.2.5 Preparing the removable devices 221
Working with data media 221
Drives 221
Inserting a CD/DVD 221
Connecting the USB storage medium 221
6.2.6 Exporting using default settings 222
Starting export 222
6.2.7 Exporting with changed settings 222
"Export to" dialog box 223
Changing the export settings 223
Starting export 225
Establishing default settings 226
6.3 Checking the data transfer 226
6.3.1 Indicators in the status bar 226
6.3.2 Viewing and processing jobs 227
Job status list 227
Influencing job performance 228
6.4 Reports 229
6.4.1 Selecting a study 229
6.4.2 Radiation Summary Report 230
Opening the report 231
Exporting the report 231
Printing a report 231

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6.1 Filming/Printing
You can expose the images of a study on film or print them on paper for documentation
and reporting.

Make sure the printer is switched on before you send images to print.

Filming and printing are the same process except that they use different output
devices. If the term "filming" or "printing" is used alone in the following, the description
applies equally for the other process.

Standard printing

You can print the displayed image or a selection of multiple images simply by pressing a
button. The print job is processed with standard settings (simplified print procedure).

Changing print settings

If you want to check or change settings prior to printing, use the "enhanced print
procedure". You can display a print preview and adapt the print layout, for example. In a
second step, you forward the print job to the required printer.

6.1.1 Selecting images

Before you start a print job, you have to select the images.

You have access to the currently loaded images through the PROCESSING task
card on the control panel. Single and multiple image selections are possible
( Page 180 Selecting images).

◆ Select the suitable display mode in the Overview menu:

Image stripe display if you want to select multiple images in the current series.

Stack display if you want to select one or more series.

Single image
◆ Select the required image or series in the Overview menu.

If the left monitor has been changed to full image mode, the image displayed there
is selected.

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Multiselection
◆ Press this button in each case to add the image or series selected in the image
overview to the multiple selection.

– or –

Switch on multiselection in the Overview menu.

Select the images or series.

Images of a multiselection are marked on both monitors by a white dot.

The Multiple Selection menu has to be open/active during printing; otherwise, only
the currently marked image/scene is printed.

6.1.2 Printing using default settings

The following default settings are used with the simplified print procedure:

• Page size and layout (page partitioning) according to the configuration settings for the
Default Printer ( Page 241 DICOM Properties - Printing).

• Handling of subtraction images and image text display as in the last print job. These
settings can be changed in the enhanced print procedure ( Page 214 Changing
print settings).

Starting printing
◆ Press this button.

The print job is started.

In the Patient list the selected images are marked as "printing" ("p" flag).

When the print job is complete the images are marked as "printed" ("P" flag).

After printing, the images are released for automatic deletion if necessary.
Depending on the hard disc fill level, the images are deleted on the specified date
( Page 246 Deleting images automatically).

The "printed" flag is set as soon as the images are successfully transferred to the printer
driver. Not all printers (e.g., paper printers) can solve printing problems themselves.
The image printout may be lost! Verify that the printouts are available before you
delete images.

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6.1.3 Printing with changed settings

In the enhanced print procedure you can change the following settings:

• Printer selection

• Layout settings

• Image text display

• Handling subtraction images

• Number of copies

Input dialog box for print settings

(1) Print settings

(2) Buttons for print, print preview, and print status

◆ Click this button on the left monitor (lower left).

The input dialog box for print settings is displayed on the monitor.

Changing print settings

The input dialog box for print settings initially contains the settings used for the last
print session.

Changes to the settings for subtraction images and image text display are used as new
default settings for standard printing.

Printer The Printer selection list contains the paper and DICOM printers configured in
the system.
◆ Select the required printer.

Layout settings Individual print layouts under an individual name are created in the configuration for
each printer ( Page 244 Print Layout task card).

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◆ Select the layout settings in the selection list.

Name: Stored print layouts for the selected printer

Size: Available page sizes for the selected printer

Layout: Available page partitions for the selected printer

Image text display The scope of image text information is defined in the configuration for each print layout
( Page 244 Image text settings).

1 Select the Anonymous option is you want to avoid assigning printed images to
a patient.

"Anonymous" appears in the hardcopy instead of the patient name. The remaining
demographic data are hidden.

2 Select the Hide Text option if all image text is to be hidden in the hardcopy.

Subtraction images Subtraction images are usually printed in native display.

◆ If needed, select the subtracted display for printing.

Number of copies

◆ Define the number of copies.

Up to 9 copies per print job are possible.

Displaying a print preview

In the print preview you can see how the images will look later on the exposed film or
paper hardcopy. You can also change the position of individual images where necessary.

1 Click this button in the input dialog box for print settings.
The images appear on the left monitor in the selected print layout.

2 Use the mouse wheel to display the individual pages of the print job.

3 Use the mouse's drag and drop function to arrange the images in the selected
page layout.

Starting printing
◆ Click this button in the input dialog box for print settings.

The print job is started.

In the Patient list the selected images are marked as "printing" ("p" flag).

When the print job is complete the images are marked as "printed" ("P" flag).

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After printing, the images are released for automatic deletion if necessary.
Depending on the hard disk fill level, the images are deleted on the specified date
( Page 246 Deleting images automatically).

The "printed" flag is set as soon as the images are successfully transferred to the printer
driver. Not all printers (e.g., paper printers) can solve printing problems themselves.
The image printout may be lost! Verify that the printouts are available before you
delete images.

Print status You can track and influence job processing for print jobs on DICOM printers.

◆ Click this button in the input dialog box for print settings.
The Job status list opens ( Page 227 Job status list).

6.2 Exporting
After an examination or postprocessing, the saved images are stored on the hard drive
(local database).

This section explains how to save images and patient data from the local database, send
them within the network, and save them to data media.

6.2.1 Export procedures

Standard export
During an examination or postprocessing, you can export the displayed image or a
selection of multiple images simply by pressing a button. The export job is processed
using default settings (simplified export procedure).

Changing the export settings

If you want to check or change settings prior to export, use the "enhanced export
procedure". You can then change the export destination and data format.

Automatic export
Depending on the configuration setting, at the end of the examination acquired images
are sent automatically to a default address ( Page 240 DICOM Properties - Sending ).

The address and export settings used are the same as for default export.

6.2.2 Export destinations

Depending on the job setting, you select one of the following export destinations in the
enhanced export procedure.

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Removable device
You write data to removable devices to save it short term or pass it on.

The following media types are supported for saving data:

• DVD-R (minus R), DVD+R

• CD

• USB storage media (external hard drives, sticks)

The accidental use of other media, e.g., DVD-RW, can result in an error message or
impair functionality.

CAUTION

Risk that CD/DVD-R media used for exporting can become damaged or be
unreadable on other CD/DVD drives.

Data loss or apparent data loss.

◆ Use removable devices as transfer media only. Only data media approved by
Siemens Healthineers may be used.

In general, do not use storage media that require their own power supply.

In addition, do not use USB storage media containing an autorun.inf file.

As a rule, you cannot release radiation during the CD/DVD write process. In exceptional
cases (emergencies), you can release radiation in fluoroscopy operating mode.
However, radiation may be disrupted.

Moreover, the export process of subtracted images to CD/DVD is interrupted during

radiation release and other processing-intensive procedures (e.g., play LSH). In those
cases images are stored as raw data.

You are therefore urgently advised to start write processes outside of examination
hours (e.g. at the end of the office day).

Other workstation
If your system is connected to a network, you can send patient and examination
data to other workstations via the network. The data can be processed or used for
diagnosis there.

Archive
To archive, you send the selected patient and examination data to a DICOM network node
that has been established as an archive. You can import archived data back to your local
database whenever you need them.

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CAUTION

Use of the imaging system hard drive as a long-term archive.

Loss of image data.

◆ Do not use the imaging system hard drive as a long-term archive. Follow the local
regulations regarding the archiving of X-ray images, while taking into account
the use of DICOM archive nodes.

CAUTION

Loss of image data.

Risk of unnecessary radiation exposure!

◆ The hard disk of the imaging system is not suitable for long-term archiving
of patient and image data. There are statutory requirements governing the
archiving period, data availability, and data security (data integrity), as well
as recommendations concerning fire protection or water damage for the
archiving of image data. The operator of the archive is responsible for observing
these regulations.
◆ Because of advances in technical development and statutory requirements, the
storage of image data and access to it cannot be realized with a single storage
and media technology alone. Therefore, the migration of data may be necessary
under the responsibility of the operator of the digital archive.

6.2.3 Overview of transfer capabilities

The figure below shows the data backup and transfer options available to you.

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(1) Export to DICOM network nodes (Archive or other workstation)

(2) Export to removable devices (CD/DVD, USB drive)
(3) Import from DICOM network nodes (Query & Retrieve) ( Page 173 Data in
the network)
(4) Importing from removable devices ( Page 172 Data from removable devices)

Please remember that not all transfer options may be available on your system. The
devices and network nodes available depend on the individual configuration of your
system and the options installed.

6.2.4 Selecting images

Before you start an export job, you have to select the images.

You can only export objects that are stored in the local database. If data are to be
transferred from one data medium to another, they must first be imported.

Exporting data from other modalities is not possible however.

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Images from an examination in progress or postprocessing

You have access to the currently loaded images through the PROCESSING task
card on the control panel. Single and multiple image selections are possible
( Page 180 Selecting images).

◆ Select the suitable display mode in the Overview menu:

Image stripe display if you want to select multiple images in the current series.

Stack display if you want to select one or more series.

Single image

◆ Select the required image or series in the Overview menu.

If the left monitor has been changed to full image mode, the image displayed there
is selected.

Multiselection

1 Switch on multiselection in the Overview menu.

2 Select the images or series.

Images of a multiselection are marked on both monitors by a white dot.

– or –

Press this button to add the image or series selected in the image overview to the
multiple selection.

The Multiple Selection menu has to be open/active during export; otherwise, only the
currently marked image/scene is exported.

Complete studies
To save or archive complete studies, select the data sets in the Patient list
( Page 165 Searching for and selecting patient data).

1 Change to the PREPARATION task card if necessary.

2 Open the Patient list.

3 Search for the patient, sorting and filtering the list as necessary.

4 Select the required study or studies.

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6.2.5 Preparing the removable devices

Depending on the routine you use, one or several drives and connections for external
data media will be established for your system.

Working with data media

Follow the instructions of the manufacturer for handling and storage of CD/DVDs.

Drives
Your system comes with a CD/DVD writer for data storage.

Inserting a CD/DVD
CDs/DVDs can be written to on one side only.

◆ Place the CD/DVD into the drive with the label facing upwards.

Never shut down the Cios Alpha or disconnect the monitor trolley from the C-arm
system while data is being written to CD/DVD.

Connecting the USB storage medium

CAUTION

Connecting/disconnecting USB devices during the exposure.

System instability, impact on or disturbance of running aquisition tasks, loss
of data.

◆ Do not insert or disconnect USB devices during exposure or other

critical processes.

CAUTION

Disconnecting USB devices during ongoing data transfer.

Loss of data and damage to the data medium possible.

◆ Do not disconnect the USB device during active data transfer (such as export).
◆ Use removable devices as transfer media only. Removable devices are not
permitted for archiving purposes.

◆ Connect the USB plug into the USB jack.

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6.2.6 Exporting using default settings

During the simplified export procedure, the settings established as defaults are
used. The default settings can be changed in the enhanced export procedure
( Page 223 Changing the export settings).

Starting export
On the control panel there is an export button whose appearance depends on the default
export destination set.

◆ Press this appropriate key.

The export job is started.

After successful completion of the export job to a network node, the selected images
are marked as sent ("S" flag) or archived ("A" flag) in the Patient list.

After exporting, the images are released for automatic deletion if necessary.
Depending on the hard disc fill level, the images are deleted on the specified date
( Page 246 Deleting images automatically).

The "sent" or "archived" flag is set as soon as the images are successfully transferred
to the network nodes. Even when the addressee works with Storage Commitment,
the flags only identify the receipt and storage of the data on the recipient's hard
drive. A misinterpretation of the flags can result in a loss of data during the prescribed
storage period. For this reason, follow the regulatory requirements regarding the
archiving procedure.

Note that the exported images are not transmitted as raw data, but including all of the
applied processing steps. They cannot be restored to their original state. Do not use
these images for the primary diagnosis!

6.2.7 Exporting with changed settings

In the enhanced export procedure you can change the following settings:

• Export destination selection

• Data format

• Image properties

• Handling subtraction images

• Saving with a DICOM Viewer

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"Export to" dialog box

◆ Click this button on the left monitor (lower left).

The Export to... dialog box appears on the monitor.

(1) Export settings

(2) Storage capacity or removable devices
(3) Buttons for export, export status, and close

Changing the export settings

In the Export to... dialog box you can first enter settings that will be used as the defaults.

Export destination ◆ Select the required destination medium from the Target Type selection list.

DICOM node: Another workstation, archive, PACS

CD/DVD: Inserted CD or DVD

USB device: Connected USB data medium

When DVD recording is active, export to DVD is not possible.

Export address When selecting "DICOM node" you have to enter a network address configured in the
system as the destination.

◆ Select the network node from the Target selection list.

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Data format The systems and applications in which the exported data can be opened and processed
depend on the data format.
◆ Select the data format in the Export Format selection list.

Private: Format that is only readable by FLC imaging systems

DICOM: Standardized file format in medical imaging

TIFF: PC graphics format

AVI: PC video format

When "DICOM node" is selected as the export destination, only the DICOM format can
be used.

Image properties Depending on the data format, prior to export images can be prepared differently in
terms of graphics and text embedding as well as file size.

When Private is selected as the data format, the data is exported only in its
original state.

◆ Select the image properties in the Export images as area.

Processed: Changes in the image display compared to the original are used (such as
window values, image rotation/flip, zoom, pan, edge filter, set black function) and
evaluation graphics are "burned" into the image.

Anonymized: "Anonymous" appears in the image instead of the patient name. The
remaining demographic data are hidden.

Downsized: The files are made smaller by reducing the image resolution 50% and the
bit depth to 8 bits/pixel.

To save the image brightness and contrast, select Processed.

Subtraction images You can export images of a specific image type or multiple image types from
subtraction series.

◆ Select the image types in the Export subtracted images as area.

Subtracted: Images in subtracted display

Native: Native images without mask and without Peak OP image

Radiation Summary Report Two different file formats are possible if the radiation summary report is exported in
DICOM format.

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◆ Select the file format in the Export Dose Report as area.

DICOM dose report: Structured Report (DICOM SR)

DICOM SC image: Image with "burned in" text

DICOM Viewer When exporting to a removable device, a DICOM Viewer is saved to the CD/DVD or
USB medium together with the image data. This allows for viewing the exported
images on any computer. The DICOM Viewer starts directly from the data medium
(automatically after inserting/connecting). No installation of files takes place on the
computer in question.

◆ Deselect this option if you do not want to save the DICOM Viewer.

Scope of data

◆ Specify the scope of the images to be exported.

Selected: all selected images (especially individually selected images)

Marked: all marked images (with white dot)

All: all images in the study

Checking disk space If a removable device is indicated as the export destination, the current storage capacity
and required disk space are displayed.

1 Use the display to check where there is sufficient space available on the medium.

2 Change the data medium if necessary before starting the export.

Starting export
◆ Click this button in the Export to... dialog box.

The export job is started.

After successful completion of the export job to a network node, the selected images
are marked as sent (“S” flag) or archived (“A” flag) in the Patient list.

After exporting, the images are released for automatic deletion if necessary.
Depending on the hard disk fill level, the images are deleted on the specified date
( Page 246 Deleting images automatically).

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The "sent" or "archived" flag is set as soon as the images are successfully transferred
to the network nodes. Even when the addressee works with Storage Commitment,
the flags only identify the receipt and storage of the data on the recipient's hard
drive. A misinterpretation of the flags can result in a loss of data during the prescribed
storage period. For this reason, follow the regulatory requirements regarding the
archiving procedure.

Export status You can track and influence job processing for all export jobs.

◆ Click this button in the Export to... dialog box.

The Job status list opens ( Page 227 Job status list).

Establishing default settings

Export jobs using the simplified procedure (standard export), automatic export, and
sending the radiation summary report at the end of the examination, are all performed
using default settings.

1 Select the required export settings in the Export to... dialog box.

2 Select the Set as Default option.

3 Click this button.

Changed default settings are stored.

6.3 Checking the data transfer

All jobs for importing, exporting, and printing/filming data are performed in
the background.
The processing of jobs can be viewed in the status bar, enabling you to react in case
of error.

6.3.1 Indicators in the status bar

The corresponding icon is displayed in the status bar on the left monitor (lower left) for
data transfers in progress. The icons indicate the action being performed and whether
an error has occurred.

Action Not active Active Error

Write to CD/DVD No icon No icon

Read from CD/DVD No icon No icon

Write to USB device No icon No icon

Read from USB device No icon No icon

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Action Not active Active Error

Export to DICOM network node (send‐ No icon

ing)

Import from DICOM network No icon No icon

nodes (receiving)

Printing/filming to DICOM printer No icon

6.3.2 Viewing and processing jobs

In the Job status list you can learn about the following jobs running in the background
– sorted by transfer type:

• Printing/filming to DICOM printer (DICOM Film)

• Export to DICOM network node (DICOM Send)

• Import from DICOM network nodes (DICOM Retrieve)

• Write to CD/DVD

• Read from CD/DVD

• Write to USB storage medium

• Read from USB storage medium

Job status list

Several methods are available for opening the Job status list:

◆ Click the Status button in the Import from, Export to dialog box, or the print
settings dialog.

– or –

Click the icon for the applicable data transfer on the left monitor.

The Job status list is displayed. The task card for the applicable data transfer
is displayed.

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(1) Tabs for selecting the transfer type

(2) Details and status of the transfer jobs
(3) Area to show the course of job processing
(4) Buttons for deleting the list or selection and to close

Influencing job performance

The work steps available in the list depend on the transfer type and the status of a job.

Jobs from all system users are displayed in the Job status list. The patient name is also
displayed. It is recommended that you delete this list manually.

Selecting jobs Some actions are limited to the transfer jobs selected in the list.

◆ Click the required jobs in the list (press and hold Ctrl for multiple selection).

Restarting DICOM Send Failed export jobs to DICOM network nodes can be repeated with the same settings or
redirected to a new address.

◆ Click Send.

The selected jobs are restarted with the original destination address.

– or –

Click Redirect.

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The selected jobs are diverted to the DICOM network node currently set in the Export
to... dialog box.

Aborting jobs ◆ Click Abort.

All transfer jobs are cancelled and the start of other planned jobs in the list
is prevented.

A data transfer in progress for which there are additional images (such as a print job
with multiple images on a page) is not cancelled.

Clearing lists ◆ Click Clear List.

All jobs that have ended or for which data transfer preparation has been completed
are hidden.

– or –

Click Clear selected.

Of the selected jobs in the list, all that have ended or for which data transfer
preparation has been completed are hidden.

6.4 Reports
Certain examination data are saved in the form of structured reports. Cios Alpha offers
the following types of reports:

• Radiation Summary Report

Use: The reports serve to document examination and treatment data. They are
mostly generated automatically. Depending on the type of report you can read, edit/
supplement, print, and export them.

Prerequisite: The examination of a registered patient is the prerequisite for a report

to exist.

Formats: Reports are saved in two different formats. This allows them to be opened in
different applications.

• Secondary Captures (DICOM SC)

Allows loading into a viewer, for example; PACS compatible.

• Structured Report (DICOM Dose)

Data format that is compatible with other DICOM systems; reports must be exported
to these systems in DICOM-SR format.

6.4.1 Selecting a study

One radiation summary report is created in the local database for each study.

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◆ Select an image or series of the required study in the PROCESSING task card on the
control panel.

– or –

In the Patient list select the study if the applicable data have not been loaded.

6.4.2 Radiation Summary Report

The radiation summary report contains the cumulated values for the number of
exposures, duration, and dose over the course of an examination. The generation
of this report is a fully automated process.

(1) Patient and examination data, cumulative radiation data

(2) Detailed information on the acquired series and images
(3) Buttons for scrolling in the report, exporting, and printing the report, as well as
closing the dialog box

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Opening the report

✓ A study or a series/image is selected.

◆ Click this button on the left monitor (lower left).

The radiation summary report is displayed on the monitor.

Exporting the report

The default settings established in the Export to... dialog box are used when exporting
the report. This is particularly true of the file format when DICOM format is set.
◆ Click this button.

The report is exported to the default address.

Printing a report
When you send the report directly to the default printer, the settings established for
standard printing are used. To use other printer settings or a different printer, open the
print preview first.

Standard printing

1 Deselect the Print on filmsheet option, if necessary.

2 Click this button.

The report is printed on the default printer.

Changing print settings

1 Select the Print on filmsheet option.

2 Click this button.

The report is opened in print preview. Make the necessary print settings and start the
print job here ( Page 214 Changing print settings).

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7 Configuration
7.1 User Settings 234
7.1.1 Opening/closing a configuration window 234
7.1.2 Site Info 234
Institution Name 235
Institutional Department Name 235
Hospital Address 235
Patient Demographic Data 235
Daylight saving time 236
Application selection 236
7.1.3 Patient registration 236
Name-display format 237
7.1.4 DICOM Properties 237
DICOM Properties - General 238
DICOM Properties - Protocol codes 239
DICOM Properties - Sending 240
DICOM Properties - Printing 241
7.1.5 Examination properties 241
Set Black 241
Nominal Power Shot 242
7.1.6 Image display and print properties 242
Display Layout task card 243
Print Layout task card 244
Image text settings 244
7.1.7 Deleting images automatically 246
Auto delete 247
7.1.8 Password for radiation release (optional) 248
7.2 Examination settings (PEX Editor) 248
7.2.1 Introduction 248
PEX Editor 248
PEX database 249
Online/offline 249
Data categories 249
Names 249
Storage capacity 249
Access control 250
Access modes 250
Import/Export 250
Automatic backup 250
7.2.2 Starting the PEX Editor 250
PEX Editor layout 252
General work steps in the PEX Editor 252
7.2.3 Editing application groups 253
Assigning applications to application groups 254
Removing applications from an application group 254
Establishing the default application group 254
7.2.4 Editing applications 255
Configure triplets for applications 255
Defining other parameters 256
7.2.5 Parameter for fluoroscopy and exposure 257
Parameter 257
7.2.6 Defining parameter sets 258

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7.2.7 PEX service functions 259

Configuration parameters 259
Changing the PEX Editor password 259
Backing up and restoring the PEX database 260

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7.1 User Settings

7.1.1 Opening/closing a configuration window

1 Change to the PREPARATION task card on the control panel if necessary.

2 Press this button.

The control panel switches to keyboard mode.

Manage Tool is displayed on the monitor.

3 Click this icon on the Settings subtask card in the Manage Tool.

The menu for defining user settings is displayed.

4 Double-click the required settings icon to open the respective settings windows.

5 Change the settings as required. See following pages.

6 Click Apply to accept the changes.

7 Click OK to confirm the changes and close the settings window.

8 Click Cancel to reject your changes and close the settings window.

9 Press this button again to exit the Manage Tool.

7.1.2 Site Info

In the Site Info dialog box you establish site-specific settings, such as the name and
address of your facility.

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Institution Name
◆ Enter the name of your hospital or practice (64 characters maximum).

A change of the Institution Name will have no effect on already acquired images.

Institutional Department Name

◆ Enter the name of your department or ward (64 characters maximum).

Hospital Address
◆ Enter the address of your hospital or practice.

Patient Demographic Data

◆ Select the patient data to display on the monitor in addition to the patient name:
Accession No.

Request ID

Patient ID

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Date of birth

Daylight saving time

When Automatic activation is selected, the system automatically switches to daylight
saving time.

Only Siemens Healthineers Customer Service is allowed to make changes to the

time settings.

Application selection
◆ Activate the Select default application after patient close check box.

When Select default application after patient close is selected, the system
automatically switches to the default application after closing patient.

7.1.3 Patient registration

In the Patient Registration Input Fields dialog box you establish what information can
be entered during patient registration.

Entries can only be made with the mouse.

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◆ Activate or deactivate the respective entries.

Visible: Entry will be shown in the Data Entry Dialog window.

Mandatory: Entry must be completed in the Data Entry Dialog window. (Entry will
be shown in the Data Entry Dialog window in bold letters).

Name-display format
Sets the parts of the patient name to be displayed:
1 Click Change.

2 Select the parts of the patient name that should be displayed (maximum five).

3 Click the corresponding check box if a comma should be placed between the parts of
the name.

4 Click OK.
The patient name composition that has been established is displayed.

This composition will be used when displaying patient names in images and on
hardcopies/filmsheets.

7.1.4 DICOM Properties

In the DICOM Properties dialog box you establish the settings for DICOM functions, such
as saving, sending, and printing of images.

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DICOM Properties - General

Storage Commitment Waiting time: The time the imaging system waits for storage commitment after a
study/images have been sent to an archive server.

Number of retries: If the archive server is not available, the imaging system performs
the selected number of retries.

If a DICOM node for which storage commitment is configured does not send a
confirmation within the configured waiting time/number of retries, neither the S (sent)
or A (archived) flag is set.

Worklist query RIS Timer: You can set the update interval (in minutes) for receiving worklist data from
the HIS/RIS (hospital/radiology information system) by specifying the update interval
(in minutes).

Possible settings: Update: 0 - 1440 minutes (24 hours), 0 = no update

Modalities to query: Selection of modality/modalities to use for worklist queries.

Any modality with a two-letter name can be entered for the worklist query (Other).

Export volumes to media Two options are available for exporting data:

• Standard

• Enhanced

Detailed dose information in Send exposure dose sequence: The exposure dose sequence is documented in the
MPPS performance documentation (MPPS).

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Extended dose info.: The dose area product and the name of the application are listed
for every exposure.

The MPPS settings can only be changed in the Service Settings and not in this dialog box.

Optional attributes Store Positioner Angle: The position data of the C-arm are stored.

DICOM Properties - Protocol codes

For MPPS Close, you can define protocol codes.

Adding a new protocol code 1 Enter the code: Code Value, Code Meaning, Code Designator, Code Version.

2 Then click Insert.

A new Protocol Code is created.

Deleting a protocol code ◆ Select the entry to be deleted from the Protocol Code list and then click Remove.

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DICOM Properties - Sending

Images for autosending ◆ Select which images are to be sent automatically:

Off: No images will be sent automatically.

All: All acquired images will be sent automatically.

Marked: Only marked images will be sent automatically.

Please note that images will be sent automatically only if a DICOM node has been
configured and set as default destination in the Export to dialog box.
( Page 226 Establishing default settings)

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DICOM Properties - Printing

Default Printer • Target: Select one of the configured printers

• Layout: Select one of the currently defined DICOM layouts

(Specification: First layout of the default printer)

7.1.5 Examination properties

Activate special performance tests to check your X-ray system in the Examination
Properties dialog box.

Set Black
Offset: You can set an offset which will be taken into account when applying the digital
collimator function.

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Digital collimator function: The areas outside the collimated areas are automatically
blackened if so configured for the selected application. ( Page 255 Editing applications)

Nominal Power Shot

Enable Nominal Power Shot: For VA (Veteran's Health Administration) hospitals in the
United States it is required to check the nominal power of an X-ray exposure at 100
kV for 100 ms in accordance with the IEC. When this function is active, the generator
creates an exposure with the nominal power when triggering a single image exposure.
The function is deactivated again automatically after triggering an exposure.

To activate the function, proceed as follows:

• The check mark for Enable Nominal Power Shot has to be set in the user settings.

• A patient has to be registered.

• A new application has to be selected (regardless of which).

– The Nominal Power Shot is active one time. (Single image and 100 kV are displayed
at this time).

7.1.6 Image display and print properties

In the Image Display and Print Properties dialog box you establish the information to
be displayed in the images when shown on the monitor and in the hardcopy.

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Display Layout task card

Image layout Display image text: Show the selected text elements in the image on the monitor.

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Print Layout task card

Image layout • Name: Print layout name

• Type: Type of print layout (Paper, DICOM)

• Size: Size of the paper/filmsheet in inches

• Layout: Page partitioning

• Enlarge patient name: Print the patient name larger than the other text

Image text settings

Top left Patient information:

• Patient name: Patient’s last name, first name

• Patient ID: Patient’s identification number

• Date of birth: Patient's date of birth

• Ward: Ward of examination

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• Request ID

• Accession No.

• Image marker

Bottom left Exposure information:

• Dose area product: Dose area product

• kV: Exposure kV

• mA / mAs: Exposure mA/mAs

• Dose value / Sensitivity class: Dose value or sensitivity

• II/FD image size: Input format/zoom level

• Image angles: Image rotation angle

• Image no.: Image number

• Application: Application program name

Center • Display Laser Crosshair at Monitor: The target crosshairs are displayed on the left
monitor as long as the laser light localizer is switched on.

• Comment: Image comment

Top right System information:

• Institution name: ( Page 234 Site Info)

• System Type: Product name

• Software Version: Product version

• Physician 1 / Physician 2: Examining physicians

• Date of exposure: Date acquired

• Time of exposure: Examination date and time

Bottom right Image information:

• Matrix size: Image matrix

• Image type: Image type

• Mask Number: Number of the mask image

• LUT level: Name of the look-up table (LUT)

• Edge level: Edge enhancement module name

• Window values: Window values

• Pixel shift values: Pixel shift values X: .../Y: ...

Image Indicators

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Dose Indicator: Displays the dose indicator in the image on the monitor.

Labeling

Label "left/right": Select text for laterality labels, depending on regional practice.

• L/R:
Display L (English: Left or German: Links) for left label

Display R (English: Right or German: Rechts) for right label

• G/D:
Display G (French: Gauche) for left label

Display D (French: Droite) for right label

• SIN/DX:

Display SIN (Latin: sinister) for left label

Display DX (Latin: dexter) for right label

Printout tag

Generic tag for sensitive printouts: Specify the text to be printed on sensitive printouts.

7.1.7 Deleting images automatically

In the Image Delete dialog box you establish the rules for automatic deletion of images
in the local database.

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Auto delete
Enable auto delete: Activate the automatic image deletion function.

If enabled, you can define the rules for automatic deletion.

• Hard disc fill level: Hard disc fill level (depending on the “memory extension” license
key) for activation of automatic deletion (60% to 90%)

• Deletion size: Amount of hard disk volume to be deleted (10% to 40%)

• Activation time: Activation time for automatic deletion (hh:mm:ss)

• Activation date: Activation day for automatic deletion (Daily/Weekly with selection
item for day)

• Conditions: Condition(s) for automatic deletion of images (any combination of the

following conditions):

– Images sent: Delete all images that have been sent to a DICOM node (with or
without confirmation of receipt).

– Images filmed: Delete all printed/filmed images.

– Images stored on CD/DVD: Delete all images stored on CD/DVD.

At least one condition has to be set to activate the automatic delete function.

• User confirmation: Obtain user confirmation before starting automatic deletion

(show confirmation dialog box).

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7.1.8 Password for radiation release (optional)

In the Radiation Release Passcode dialog box you change the password required for
radiation release.

1 Enter the old password.

2 Enter a new password (four-digit number).

3 Repeat entry of the new password.

4 Click OK.

7.2 Examination settings (PEX Editor)

7.2.1 Introduction
The Cios Alpha system provides a series of applications and acquisition program triplets
for standard examinations.

The applications are divided into application groups and saved in a database.

The fluoroscopy and acquisition parameters are established in the applications.

All Fluoro, ROAD, DR (Single image), SUB, and DCM acquisition programs are available
as versions with low, medium, and high dose.

Operating mode Fluoro ROAD SUB DR DCM

Low x x x x x

Medium x x x x x

High x x x x x

An application comprises three acquisition program triplets each (low, medium, high) for
each operating mode (fluoro, single image, subtraction, roadmap).

PEX Editor
The Programs and Exams Editor, PEX Editor for short, is a tool for viewing and editing
application groups, applications, and acquisition program triplets. You can also define
parameter sets that can be used with the acquisition programs.

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The PEX Editor may be used by authorized persons only.

PEX database
The PEX Editor administers a database, the PEX database, containing the definitions
of the application groups, applications, and acquisition program triplets, as well as the
parameter sets.

Online/offline
The PEX Editor runs on the Cios Alpha.

Offline editing of the PEX database is also supported. A special version of the PEX Editor
runs on a separate Windows PC without the main application.

Data categories
The PEX database supports the storage of the following data types:

• User data

Your specific applications and application groups.

• Siemens Healthineers data

– Standard applications, application groups, parameter sets, and program triplets.

These entries are marked with (d) = default.

– IQAP applications, application groups, and parameter sets. These entries are
marked with (i) = IQAP.

– Calibration applications, application groups, and parameter sets. These entries are
marked with (c) = calibration.

– Service programs for maintenance. These entries are marked with (m)
= maintenance.

Names
The names of the applications, application groups, parameter sets, and program triplets
depend on the language set for the user interface:

• The names of Siemens Healthineers elements depend on the language set for the user
interface. In other words, every element has a different name in each configurable
language, but the parameters are the same in each language.

• User specific applications and application groups do not depend on the set language.
In other words, there is only one name for all configurable languages.

Storage capacity
The following number of programs can be stored in the database:

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• Up to 44 activated application groups, i.e., up to 44 application groups that can be

selected on the control panel

• Up to 3000 applications

• Up to 44 applications per application group

• Up to 30 application program triplets per application

Access control
To open the PEX Editor you are asked to enter a password or to select the viewing mode.
The customer mode password is site-specific. It can be set up and edited. In service mode,
the customer mode password can be reset without knowledge of the current password.

Access modes
There are three modes for accessing the data:

• In Customer mode, you have access rights for user data and also for viewing the
standard applications and application groups. Access to IQAP, calibration, and service
data is not possible.

• In IQ expert mode, Siemens Healthineers image quality experts have access to view
and edit all data.

• In Viewing mode, you can see all data sets, but you cannot modify them.

Import/Export
You can import a PEX database into the PEX Editor via any local or external drive e.g. local
hard drive, a CD/DVD drive, or a USB storage medium. Each import replaces the current
database and cannot be undone.

Depending on licensing, several applications/acquisition programs may be inactive after

the transfer. Inactive applications/acquisition programs cannot be selected.

Automatic backup
Backups of the PEX database are done automatically. The automatic backup runs in the
background after each editing session when the PEX Editor is closed.

Up to ten backups are kept in a folder on the hard drive.

A database stored via automatic backup can be restored with the import function.

7.2.2 Starting the PEX Editor

1 Change to the PREPARATION task card on the control panel if necessary.

2 Press this button.

Manage Tool is displayed on the monitor.

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3 Click this icon on the Settings subtask card in the Manage Tool.

The password dialog box for the PEX Editor is displayed.

The factory-set password for customer mode is: customer.

4 Select Customer mode.

5 Enter the correct password.

6 Click Ok or press Enter.

The PEX Editor is opened for editing.

– or –

Click Ok for Viewing only.

The PEX Editor is opened for viewing only.

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PEX Editor layout

Example

The PEX Editor includes the following task cards:

• Application Group: Add or remove applications from application groups.

• Application: Establish acquisition program selection and properties within

an application.

• Triplets: Establish acquisition program triplets for Fluoro, SUB/ROAD, DR, and DCM
operating modes.

• Param. Module: Define and edit parameter sets referenced in the

acquisition programs.

• Configuration: Define and edit system configuration data, e.g. language

configuration, generator type. Functions for backup/restore of the PEX database
are also located here.

General work steps in the PEX Editor

◆ Check/modify the parameters.

( Page 253 Editing application groups)

( Page 255 Editing applications)

( Page 257 Parameter for fluoroscopy and exposure)

Adopting changed parameters ◆ Click Store.

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Creating a new application 1 Enter a new designation for Application Group Name or Application Name or
group/application or a new Triplet Name.
acquisition program triplet
2 Click Store as new.

Deleting an application group/ 1 Select the element.

application or an acquisition
2 Click Delete.
program triplet
A confirmation dialog box appears.
3 Click Yes to delete the element.

A triplet used in an application cannot be deleted.

Siemens Healthineers standard triplets can only be deleted in IQ expert mode.

Rejecting changed parameters

1 Click Close.

– or –

Click the Close icon.

A confirmation dialog box appears.

2 Click Ok to reject changes.

7.2.3 Editing application groups

Example

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The Application Group task card displays all available applications and application
groups. You define application groups and assign applications to the application
groups here.

• The applications are listed in the Application List.

• The application groups and all assigned applications are listed in the Application
Group List.

( Page 252 General work steps in the PEX Editor)

The Application Group Name comprises a maximum 15 Unicode characters.

Assigning applications to application groups

1 Mark an application in the Application List.

2 Mark an application group in the Application Group List.

3 Click Insert Application.

– or –

Drag an application from the Application List to an application group in the

Application Group List.

The application is assigned to the application group under the position marked in the
Application Group List.

The same application can be assigned to multiple application groups.

Removing applications from an application group

1 Mark the application in the Application Group List.

2 Click Remove Application.

Establishing the default application group

◆ Mark the application in the Application Group List and then click Set as default.

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7.2.4 Editing applications

Example

The Application task card shows the assigned acquisition program triplets for the
Fluoro, SUB, ROAD, DR, and optional DCM operating modes, as well as additional
parameters. You can configure the applications and establish the application-specific
parameters here.

( Page 252 General work steps in the PEX Editor)

The Application Name comprises a maximum 15 Unicode characters.

Configure triplets for applications

1 Select a triplet for each operating mode.

2 Activate the Auto Window to switch to automatic window value assignment for
SUB/ROAD.

The brightness and contrast settings of the currently available Peak OP image are
used when reviewing the subtraction scene or for subsequent subtraction exposures.

3 For automatic saving activate the Auto-store option field and enter the Storage Rate
and Max scene length.

The maximum scene length is set in seconds.

The percentage save frequency (save rate) corresponds to the proportion of images
to be saved from the live scene; e.g., at a 25% save rate, every 4th image is saved.

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CAUTION

Storage rate is set incorrectly or being not aware of replay/image

saving behavior.

Images are lost or replay rate/image saving differs from the pulse rate
during acquisition!
◆ Choose the storage rate with care.
◆ Note that for 30 frames per second with 30x30 detector in MAG 1 or with
20x20 detector in overview, image information is summarized in 15 frames
for replay/storage only (no image information is lost).

4 Activate Autoreplay if scenes should replay automatically.

5 For SUB/ROAD establish the Number of frames for mask, i.e., the number of images
used to calculate the mask.

Defining other parameters

1 Select an entry in the Name Module of Contrast Automatic list to establish the
brightness and contrast.

2 Select a multiplication factor for Toggle function EE.

The user can toggle the edge enhancement between low, default, and high on the
control panel. The default value is set in the triplet. The values for low and high are
calculated by a factor.

A factor of 1 means the edge enhancement is medium.

A factor of 0 means the edge enhancement is off.

3 Select a multiplication factor for Toggle function MD.

The user can toggle the motion detection (k factor) between low, default, and high
on the control panel. The default value is set in the triplet. The values for low and high
are calculated by a factor.

A factor of 1 means the motion detection is medium.

4 Select a Center Shift and a Width Factor for LUT Preset 3.

The values for center shift and width factor can be set for automatic contrast
regulation. Correction values for center/width and brightness/contrast of the third
LUT can be set.

5 Activate Set Black if the image area outside the collimated area should be blackened
(digital collimation).

6 Define the input values for Rotation in degrees (0 - 359), Flip (vertical and⁄or
horizontal flip) and Magnification (Level 0, 1, 2).

7 Establish the measurement field with the Measurement parameter.

8 Switch between small and large focus with the Focal spot size parameter.

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7.2.5 Parameter for fluoroscopy and exposure

Example

The Triplets task card enables triplets and parameters to be established for all operating
modes on the corresponding cards.

• Fluoro card: Parameters for unsubtracted fluoroscopy

• SUB/ROAD card: Parameters for subtracted fluoroscopy

• DR card: Parameters for unsubtracted single image acquisitions

• DCM card: Parameters for digital cine mode (only available with the DCM option)
( Page 252 General work steps in the PEX Editor)

Parameter
Triplet Name: Name of the fluoroscopy or acquisition program triplet (max.
63 characters).

• Number of Images: Number of images from which the LIH (last image hold)
is calculated.

• Number of Images IDL: Number of pulses used to calculate the individual images in
Fluoro and SUB/ROAD modes.

• Number of Pulses: Number of pulses to obtain a specific overall dose for a single
image acquisition.

Examples: A factor of 1 corresponds to a single acquisition. With a factor of 8, the

image is calculated from 8 acquisitions. Possible values: 1, 2, 4, 8, 16, 32

• Landmark: Basic setting for anatomical background in subtracted images. Possible

values: 0 - 100%

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• Parameter modules Noise Time Filter, Noise Spatial Filter, Spatial Frequency
Response: Three parameter sets can be selected for each dose level. The parameter
sets are defined by experts. ( Page 258 Defining parameter sets)

• Default: Establish the default parameter set: Low or Medium. High cannot be
selected as the default.

7.2.6 Defining parameter sets

Example

Parameter sets can be defined and edited on the Param. Module task card. These can
then be referenced in application and/or triplet definitions.

Parameter sets may be changed in expert mode only; changed parameter sets cannot
be saved in customer mode.

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7.2.7 PEX service functions

Configuration parameters

• Units for: Unit to be used (cm or inches) for the Collimator Size

• Password: ( Page 259 Changing the PEX Editor password)

• Database Export/Import: ( Page 260 Backing up and restoring the PEX database)

• Restore/Import Database Selection: Database selection for export/import

• Pex Versions: Displays the PEX Editor version

Changing the PEX Editor password

1 Click the Configuration card.

2 Click Change Password.

The password change dialog is displayed.

3 Enter your old password.

4 Enter your new password.

5 Re-enter your new password.

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6 Click Ok.

Backing up and restoring the PEX database

It is possible to import or export the PEX database via a local or external drive (e.g. local
hard drive, CD/DVD drive, USB memory stick).

This process should only be perform by an expert or specialist.

◆ Click the Configuration card.

Exporting the PEX database 1 If necessary, have the required external data medium on hand.
Insert a blank CD/DVD into the drive.

Connect the USB memory to the USB socket.

2 Click Backup / Export.

A list of all writable devices connected to the PC in use (system or user PC with offline
PEX Editor) that can be used for export/backup is displayed.

3 Select the destination drive.

4 Click Go to start export.

The PEX database is copied to the destination drive in a predefined folder (e.g.
D:\PEX_backup\). The name of the database copy is the original name extended by
creation date and time.

A message window indicates that the backup is complete.

5 Click OK.

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The number of backups on the local drive (C: and D: drives) is limited to 10.

Importing a PEX database By importing you replace the old system database. If an error occurs during transfer, the
old database remains valid.

After correct import the old database is permanently deleted.

1 If necessary have the required external data medium to which the new database will
be stored on hand.

Insert the CD/ DVD into the drive.

Connect the USB memory to the USB socket.

2 Select the database you want to replace.

Customer DB, Service DB, or Both for both databases.

3 Click Restore / Import.

A list of all readable devices connected to the PC in use (system or user PC with offline
PEX Editor) that can be used for import/restore is displayed.

4 Select the source device.

A list of all restorable databases is shown.

When copying from the local hard drive you have to select one of the two backup
folders (manual, automatic backup) to get the list of restorable databases.

5 Select the new database or databases.

6 Activate Assure data consistency if the data are to be checked for errors.

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7 Click Go to start the import.

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8 Maintenance
8.1 Functional and safety checks 264
8.1.1 Daily checks 264
Prior to the examination 264
Checking the EMERGENCY STOP function for motor-
driven system movements 264
8.1.2 Monthly checks 264
Functional check of the dose rate control 264
8.1.3 Checks prior to special examinations (e.g. of the open heart
and skull) 265
8.1.4 Network administration and calibration 265
8.1.5 Maintenance plan for checking the system 265
8.1.6 Maintenance intervals 266
General information on maintenance intervals 266
Batteries 266
Dose measurement chamber 267
8.1.7 Dose and consistency test 267
Preparation 267
Dose measurement 268
Calculation 268
8.2 Service via network connection 269
8.2.1 Smart Remote Services 269
Software updates via remote access 269
Setting access rights 269
8.2.2 Application support 270
8.2.3 Transmitting error messages 272
Transmitting to the factory 272
Saving to a USB drive 273
8.3 Software Update 273
8.3.1 Software update failed but system recovery was successful 275
8.3.2 Software update and system recovery failed 276
8.4 Protection classes/Protection measures 276
8.5 Cleaning and Disinfection 277
8.5.1 Active ingredient classes 277
Not recomended cleaning agents and products 277
8.5.2 Preparing the C-arm system 277
8.5.3 General cleaning and disinfection measures 278
Combining the cleaning and disinfection process 279
Material damage 279
Transport and park position of the C-arm system and the
monitor trolley 280
8.5.4 Cleaning and disinfection areas 280
Surfaces of the C-arm system 280
Surfaces of the monitor trolley 281
8.5.5 Cleaning procedure 282
8.5.6 Disinfection procedure 282

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8.1 Functional and safety checks

To ensure that the Cios Alpha is ready for operation and all safety features are functioning
properly, you must perform regular functional and safety checks.

8.1.1 Daily checks

Prior to the examination

1 Check the power plug. If the power plug is damaged, the Cios Alpha must not
be used.

2 Check the power cable. If the power cable is damaged, the Cios Alpha must not
be used.

3 Check the function of the locking brakes of the C-arm system and the monitor trolley
as well as the steering of the C-arm system.

4 Check the C-arm counterbalance after releasing the brakes.

5 Check the loudspeakers for proper functioning. An audible signal must sound while
the system starts up.

6 Check that all radiation indicators are functioning properly.

7 Inspect the flat detector unit housing and the single tank for mechanical damage.

8 Check that the anti-scatter grid and the knurled screw are fastened properly.

Checking the EMERGENCY STOP function for motor-driven

system movements
1 Switch the Cios Alpha on.

2 Move the lifting column and press the EMERGENCY STOP button at the same time.

The lifting movement is stopped.

A message is displayed on the monitor indicating that EMERGENCY STOP has

been actuated.

3 Release the EMERGENCY STOP button.

4 Press one of the buttons for moving the lifting column.

The lifting movement is enabled again.

8.1.2 Monthly checks

Functional check of the dose rate control

You can check the function of the dose rate control without an object using the simple
procedure described below. A kV value of ≤ 45 kV must stabilize:

1 Open the rectangular and slot collimators to maximum aperture.

2 Press the Tech lock button and select Stop.

3 Select 125 kV with the +/- buttons.

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4 Press the Tech lock button again and select Auto.

The stop function is canceled; automatic dose rate control is switched on again.
5 Release radiation in fluoroscopy mode.

The tube voltage is reduced to a value ≤ 45 kV.

The monitor image is not overexposed.

8.1.3 Checks prior to special examinations (e.g. of the open heart

and skull)
◆ Make sure that there is an additional conductive connection between the C-arm
system and a point of potential equalization, e.g. the patient table.

8.1.4 Network administration and calibration

1 In the PREPARATION subtask card, press the Data system button on the monitor
trolley control panel.

Manage Tool is displayed on the monitor.

2 Click the Service subtask card on the monitor.

3 Click Service login. Alternatively, on the control panel press the Service login button
on the lower right.

The Service login screen appears.

You will find detailed instructions on network administration and calibration in the
separate operator manual “User Administration Guide”.

8.1.5 Maintenance plan for checking the system

The tests and inspections required by national laws or regulations, such as DHHS
regulations or StrlSchG (constancy tests), are not part of the activities listed in this
maintenance plan.

If national laws or regulations specify more frequent checking and/or maintenance,

these must be observed.

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Maintenance work should be performed by trained technical personnel only. To keep

the system in an optimum condition, we recommend that you conclude a maintenance
contract. If you have any questions relating to maintenance/maintenance contract
please contact our Siemens Healthineers Customer Service.

Please observe the relevant information in ( Page 21 Maintenance and inspection).

8.1.6 Maintenance intervals

General information on maintenance intervals

Regular maintenance takes place in 24-month intervals. It contains numerous
maintenance steps that have to be performed:

Procedures to be performed Function Interval

External visual inspection Damage, total system 24 months

Mechanical safety Covers, cable guards, C-arm, C-arm 24 months

movements, anti-scatter grid/grid
holder, brakes. C-arm system and
monitor trolley wheels, lifting col‐
umn, emergency stop button, warn‐
ing labels, identification labels, moni‐
tors, options (if present, e.g. motorized
movements, laser light localizers)

Electrical safety Cable and plug, network connection 24 months

socket, fluoroscopy indicator, acous‐
tic warning signal, radiation release
switch, radiation indicator, dose area
product and/or air kerma measuring
device, options (if present), total sys‐
tem image quality, checks in accord‐
ance with IEC 62353

Maintenance System ventilation, C-arm guide wires, 24 months

C-arm spindle, cleaning of system

Operating value inspection Output and assess Event Log 24 months

Functional inspection Control functions, monitor indicators 24 months

of beam path opening/slot collimator
positions, options

Upkeep Housing 24 months

The stated functions are minimum requirements.

Batteries
Battery replacement intervals (UPS and PC)

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Procedures to be performed Function Interval

Operating value inspection UPS lead gel batteries Every 48 months

PC bios battery

The stated functions are minimum requirements

Dose measurement chamber

The dose measurement chamber is calibrated on a regular basis as part of the
maintenance contract (every 5 years at the latest). If you do not have a maintenance
contract, Siemens Healthineers Customer Service or the manufacturer can calibrate the
dose measuring chamber.

8.1.7 Dose and consistency test

Carry out dose area product testing after performing the following procedure:

Preparation
1 Open the collimator completely (full format).

2 Select the "Fluoroscopy" operating mode.

3 Center the lead ruler on the flat detector.

4 Release radiation, setting the rectangular collimator to approx. 15 cm edge length.

5 Keep the field size (shown on the lead ruler) constant.

The rectangular collimator may no longer be adjusted.

6 Remove the lead ruler.

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7 Center the dose measurement device on the flat detector (see (1) in graphic).

(1) Dose measurement device

Dose measurement
1 Release radiation for a short period and then actuate the Tech lock button and set
70 kV.

2 Record the dose area product - value "A" (µGycm2) - shown on the monitor.

3 Set the measured dose area product to "0" on the measuring device.
4 Release radiation for approx. 10 s and record the measured dose (cGy).

5 Record the dose area product - value "B" - shown on the monitor.

6 Subtract value "A" from value "B".

Calculation
Measured dose area product = measured dose (cGy) x 225 cm2

◆ Compare the measured value with the dose area product displayed on the monitor.

With a correct adjustment, the displayed and calculated values agree within a
maximum deviation of +/- 25%. If the deviation exceeds this percentage, please
inform service.

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8.2 Service via network connection

The Cios Alpha must be connected to a network (DSL ≥ 1 Mbit/s) to enable remote access
service measures.

8.2.1 Smart Remote Services

If the rights are granted accordingly, Siemens Healthineers Customer Service can
access the Cios Alpha for maintenance and installation activities via an active
network connection.

Software updates via remote access

CAUTION

Software installation interferes with system functions.

Interruption of patient examination and loss of patient data.

◆ Do not start the installation while working with patients.

CAUTION

Failure installing the update package.

A failed software installation means that the system is in an undefined state.

◆ Stop using the system and notify the UPTIME Service Center.

CAUTION

No restart after service session.

Changes to the service environment may not go into effect without a

system restart.
◆ Restart the system after a service session.

Setting access rights

In the Remote Service window you grant service personnel access rights so that they
can perform maintenance in a remote session.

The patient must be closed; otherwise, there could be problems accessing the
control panels.

1 In the PREPARATION subtask card, press the Data system button on the monitor
trolley control panel.

Manage Tool is displayed on the monitor.

2 Click the Settings subtask card on the monitor.

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3 Double-click the Telephone icon.

The Remote Service window appears.

4 Click one of the following options to define the type of access:

Full access: Service receives full access rights to your system.

Limited access: Service receives limited access, that is, they can see error messages
and reset passwords.

No access (default setting): Service does not receive access to your system.

5 Click OK to apply all settings and exit the window.

6 Press the “X” button to exit the Manage Tool.

8.2.2 Application support

If you require online support for your system, you can grant access to the Cios Alpha
as follows:

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1 Right-click the i icon (1) on the monitor.

The Headquarter Support Applications screen opens:

2 Click Remote assistance.

The Remote Assistance window opens.

3 To enable remote access to the system click I agree.

The dialog window with instructions and input fields for starting the remote service
session opens.

If you click I do not agree, remote access to the system is rejected and the
request canceled.

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4 Enter the Connection ID and the Password that you have received from Service.

5 Click Continue.

The requesting technician receives the right to control the user interface.

The remote assistance status is displayed in the status area.

8.2.3 Transmitting error messages

You can transmit error messages directly to the factory or save them to a USB drive.

Transmitting to the factory

1 Click the i icon.

The Headquarter Support Applications screen opens.

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2 Under Send to factory mark the appropriate check box.

3 You can also enter a comment by marking the appropriate check box and
entering text.
4 Confirm with OK.

The message and/or log files are sent.

If the system is not currently connected to the network, the files are placed in a
transfer folder on the system. The files are sent the next time a network connection
is established.

Saving to a USB drive

1 Insert the USB drive into a free USB slot on the monitor trolley.

2 Click the corresponding box and confirm with OK.

The log files will be saved to the USB drive.

8.3 Software Update

The installation of a software update can be initiated by any user. Each available software
update package on the system is indicated by a standard window, the so called SD GUI
(Software Distribution Graphical User Interface).

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1 Press Install

An additional dialog is shown, which needs to be confirmed

The button Defer will close the window and provide the software update during the
next system startup again.

2 Press OK to start the software update

Pressing Cancel will close the dialog and the SD GUI and will not trigger the
software update.

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The installation progress and the estimated installation time is displayed in the next
window. This window remains displayed during the entire installation process.
3 Follow the instructions on the monitor and do not shut down the system

After the installation of the software update is finished an automatic reboot of the
system is triggered. During the system startup the following dialog is displayed to
indicate that additional tasks will be done in the background.

4 Follow the instructions on the monitor and do not shut down the system

The successfully finished software update is displayed to the user

8.3.1 Software update failed but system recovery was successful

In case of any error during the installation of the software update the system will be
automatically rolled back to the initial state (before the software update). The successful
recovery is indicated by the following screen:

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◆ Pressing the button OK

The window will close and the system is ready to use

8.3.2 Software update and system recovery failed

In case the software update and the attempt to recover the system to its initial state fails
the system is locked. The following screen is displayed:

◆ The system cannot be operated. Please call your administrator to contact the
service department

Even after switching the system off and on again the screen will show the same
message. There is no way to confirm this screen, the system must be repaired by a
service engineer

8.4 Protection classes/Protection measures

System components Protection class Protection measures

X-ray tube assembly (Single-tank) IPX0 - No protection protect with sterile cover

Flat detector IPX0 - No protection protect with sterile cover

C-arm IPX0 - No protection protect with sterile cover

Remote control unit (optional) IP65 dust tight, protected against protect with sterile cover, separate
water jets from chassis before cleaning

Standard footswitch IPX8 protected against immersion protect with sterile cover, separate
beyond 1 m from chassis before cleaning

Multifunctional footswitch IPX8 protected against immersion protect with cover, separate from chas‐
beyond 1 m sis before cleaning

Multifunctional footswitch, wireless IPX8 protected against immersion protect with cover, separate from chas‐
beyond 1 m sis before cleaning

Hand switch IP54 dust protected, protected against separate from chassis before cleaning
splashing of water

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8.5 Cleaning and Disinfection

Clean and disinfect all parts that could have come into contact with the patient and
personnel or body fluids immediately after each examination. In addition, if the Cios
Alpha remains unused for a longer period of time, clean all parts that could come into
contact with the patient and personnel or body fluids before the next examination. Any
dust deposits on the housing of the flat detector, the single tank, and the C-arm need to
be removed prior to operation.

Please follow the cleaning and disinfection instructions as described below.

8.5.1 Active ingredient classes

A non-protein-fixing VAH-listed disinfectant with proven cleaning effect based on
peroxide chemistry is recommended.

Disinfectant wipes ECOLAB Incidin OxyWipes S or the disinfectant cleaner Dismozon

plus were used to validate cleaning and disinfection instructions ( Page 278 General
cleaning and disinfection measures).

Active ingredient classes compatible with the Cios Alpha are listed below.

Active ingredient class Aldehydes, alkylamines, quaternary compounds,

guanidine derivatives, peroxide compounds,
organic acids, chlorine derivatives, alcohol,
benzene, common household dishwashing liq‐
uids, detergents

Not recomended cleaning agents and products

CAUTION

Use of unsuitable cleaning agents.

Risk of contamination.

◆ Only use the recommended cleaning agents and disinfectants.

Certain substituted phenol-based or chlorine-splitting disinfectants can corrode

materials and are therefore not recommended.

Cleaning agents and disinfectants containing chlorine derivatives can discolor cables,
but will not negatively impact system functions.

8.5.2 Preparing the C-arm system

Before starting cleaning and disinfecting the Cios Alpha, the C-arm must be adequately
positioned to reach the surfaces properly.

1 Have the C-arm raised beforehand using the vertical lift.

2 Make sure that all surfaces, grooves, notches etc of the Cios Alpha can be reached
during the cleaning and disinfecting process.

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CAUTION

Inadvertent actuation of the foot pedal.

Risk of radiation!

◆ Switch off the system before cleaning.

3 Switch off the Cios Alpha and disconnect from mains power supply

4 Separate hand switch, footswitch and additional accessories from the Cios Alpha.

8.5.3 General cleaning and disinfection measures

WARNING

Fluid or blood seeps into the system, use of inappropriate cleaning agents.

Risk of damage to the system, risk of infection or electrical hazard!

◆ Use sterile or sterilizable covers.
◆ Do not let cleaning liquids seep into the openings of the system (e.g. air
openings, gaps between covers).
◆ Observe the cleaning and disinfection instructions.
◆ Only use the recommended substances for cleaning and disinfection.

CAUTION

Improper cleaning.

Risk of infection!
◆ After dealing with patients with highly infectious diseases, clean the unit
wheels, in addition to regular cleaning.

Never immerse system parts (except for the footswitch) in liquid or autoclave system
parts! Observe the respective protection and active ingredient classes in this regard.

1 While cleaning and disinfecting, wear chemical resistance gloves and protective gear.

2 Prepare the cleaning and disinfection solution according to the manufacturer's

instructions (tap water, minimum drinking water quality at room temperature) or use
ready-to-use wipe systems.

3 Always adhere to the disinfectant manufacturer's instructions for use regarding

handling and exposure time of the disinfectant solution.

Some substances contained in disinfectants are known to be hazardous to health.

The concentration of such substances in the air must not exceed the legally defined
limit. We recommend that you follow the manufacturers’ usage instructions for these
products (active ingredient classes).

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4 Prepare an adequate number of lint-free mops and lint-free wipes for the cleaning
and disinfection of the Cios Alpha.

Do not use any brushes as they can damage the labels attached to the Cios Alpha.

5 If the floor is visibly soiled, disinfect the floor under and directly around the
mobile C-arm.

6 Visually inspect all surfaces on the C-arm, C-arm chassis, and all surfaces of the
monitor cart for visible contamination and proceed with the corresponding cleaning
and disinfection steps as described in the respective sections:

( Page 282 Cleaning procedure)

( Page 282 Disinfection procedure)

7 Always work from top to bottom (top down) and from clean to dirty areas.
( Page 280 Cleaning and disinfection areas)

8 If disinfectants with longer residence times are used, it may make sense for reasons
of infection prevention to first disinfect surfaces near the patient and then the more
distant surfaces.

9 Use lint-free mops and lint-free wipes only as long as they leave a closed liquid film
on the surface.

10 Should blood be wiped off, discard the lint-free mop or lint-free wipe and use a new
one to continue the cleaning and disinfection procedure.

11 Dispose used lint-free mops and lint-free wipes according to the instructions of
your facility.

12 Let the surfaces of the Cios Alpha and the floor dry completely before further use.

Combining the cleaning and disinfection process

A cleaner-disinfectant enables in most cases a one-step process that eliminates the
need for a cleaning step before each disinfection step. However, the use of a cleaner-
disinfectant does not replace regular cleaning: If the mobile C-arm is heavily used,
weekly cleaning of all regularly disinfected surfaces is strongly recommended. A regular
cleaning step is required to ensure good hygiene practices, to maintain the integrity of
the material in the long term and to avoid the formation of residues. This cleaning step
is important regardless of whether cleaner-disinfectants or only disinfectants are used
for disinfection.

Material damage

In the case of a material damage, please notify Siemens Healthineers

Customer Service.

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 8 Maintenance

Transport and park position of the C-arm system and the

monitor trolley

For transportation and parking position, please follow the instructions in

the corresponding sections. ( Page 91 Transporting the C-arm system),
( Page 94 Transporting the monitor trolley)

8.5.4 Cleaning and disinfection areas

Surfaces of the C-arm system

Particular parts of the C-arm Graphic reference number

Control unit (1)

Remote control unit (optional)

Horizontal support arm (2)

Handles on both sides of the electronics unit (3)

including hand switch with cable

Steering lever (4)

Lifting column (5)

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 8 Maintenance

Particular parts of the C-arm Graphic reference number

Electronics unit (6)

Footswitch with cable (Standard) (7)

Multifunctional footswitch (optional)

Flat detector with grid (8)

C-arm with handles for manual movements (if (9)

possible in vertical position)

Single tank (10)

Wheels with cable deflectors (11)

Surfaces of the monitor trolley

Particular parts of the monitor trolley Graphic reference number

Monitors with monitor column (1)

Control panel (2)

Handles for neat cable storage (3)

Drawer (4)

Wheels with cable deflectors (5)

Shelf for printer (6)

Central locking brake (7)

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8.5.5 Cleaning procedure

The following steps must be followed for all surfaces listed ( Page 280 Cleaning and
disinfection areas):
1 Wipe the surfaces of the product thoroughly with sufficiently saturated lint-free
wipes for cleaning.

2 Make sure that all surfaces, existing grooves and bumps of the product are reached
during the cleaning process and are completely moistened.

3 Soak a lint-free wipe with tap water and wipe all surfaces of the product thoroughly.

4 Check for cleanliness; if soiling is still visible, repeat the above steps

8.5.6 Disinfection procedure

The following steps must be followed for all surfaces listed ( Page 280 Cleaning and
disinfection areas):

1 Thoroughly wipe the surfaces of the product one more time with a sufficiently
saturated disinfection lint-free wipe.

2 Make sure that all surfaces, existing grooves and bumps of the product are reached
during the disinfection process and are completely moistened.

3 Follow the manufacturer’s instructions regarding the exposure time of the

disinfectant solution.

4 Soak a lint-free wipe with tap water and wipe all surfaces of the product thoroughly.

5 Let the device dry.

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 9 Technical Specifications

9 Technical Specifications
9.1 Curves and diagrams 285
9.1.1 Heating curve without cooling 285
9.1.2 Heating curve with cooling 285
9.1.3 Position of focus and Source-to-Image Distance (SID) 287
9.1.4 Small focus (0.3) emission curves 287
9.1.5 Large focus (0.5) emission curves 288
9.1.6 Dose rate at the flat detector input 288
Dose rate value deviation 288
Setting the dose rate value 288
9.1.7 Fluoro curves 288
Systems with 25 kW generator 289
Systems with 12 kW generator 290
9.1.8 Dosimetric information 292
Reference air kerma and reference air kerma rate 292
Dosimetric information in accordance to IEC
60601-2-43:2010 301
9.2 Precautions for EMC – 3rd Edition 304
9.2.1 Guidelines and manufacturer's declaration –
Electromagnetic emissions 304
9.2.2 Guidelines and manufacturer's declaration –
Electromagnetic interference immunity 305
9.2.3 Guidelines and manufacturer's declaration –
Electromagnetic interference immunity 306
9.2.4 Recommended separation distances between portable and
mobile RF telecommunications equipment and the system 307
9.3 Precautions for EMC – 4th Edition 308
9.3.1 Declaration of immunity and emission compliance 308
9.3.2 Declaration of EMC environment 309
9.3.3 Adjacent or stacked equipment 309
9.3.4 List of cables, transducers and accessories 309
9.3.5 Usage of other accessories, cables and transducers 309
9.3.6 Portable RF communication equipment 310
9.3.7 Note for CISPR11 class A equipment 310
9.3.8 Degradation and loss of the essential performance caused
by electromagnetic interferences 310
9.3.9 Instructions for maintaining basic safety and essential
performance with regard to electromagnetic disturbances
for the expected service life 310
9.3.10 Use of equipment nearby of emitters 310
9.4 Original equipment manufacturer 311
9.4.1 Introduction 311
9.4.2 For Open Source Software (OSS) only 311
9.5 System data 312
9.5.1 Entire system 312
General data 312
Weight 313
Classification 313
Current/voltage values 313
9.5.2 Generation of radiation 313
X-ray generator 313
X-ray tube assembly (Single-tank) 315

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 9 Technical Specifications

9.5.3 Image receptor 315

Flat detector 20x20 316
Flat detector 30x30 317
9.5.4 Unit components 317
C-arm 317
Collimator system 318
Imaging chain 318
Dose measuring chamber (DAP meter) 318
Monitors 318
9.5.5 Equipment options 320
Detector laser light localizer (red) 320
Detector laser light localizer (red, 1 mW) 320
Single-tank laser light localizer (red) 320
HD video manager 320
DVI video splitter 321
WLAN access point 321
Footswitch wireless 321
Footswitch wireless receiver 322
9.6 Labels 322
9.6.1 C-arm system 322
1. Base system (Chassis) 324
2. Horizontal support arm 325
3. Control panel for C-arm system 325
4. Control module for the motorization package 325
5. Anti-scatter grid 325
6. C-arm inside 326
7. Remote control unit (optional) 328
9.6.2 Monitor trolley 329
9.6.3 Pictograms 329

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 9 Technical Specifications

9.1 Curves and diagrams

9.1.1 Heating curve without cooling

Heat storage capacity single tank SMB30 without cooling, Undertable/Overtable:

(1) yellow curve: cooling curve

(2) light blue curve: 100 W, Overtable
(3) dark blue curve: 100 W, Undertable
(4) light green curve: 300 W, Overtable
(5) dark green curve: 300 W, Undertable
(6) pink curve: 600 W, Overtable
(7) red curve: 600 W, Undertable

9.1.2 Heating curve with cooling

Heat storage capacity single tank SMB30 with cooling, Undertable/Overtable:

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(1) yellow curve: cooling curve

(2) light blue curve: 100 W, Overtable
(3) dark blue curve: 100 W, Undertable
(4) light green curve: 300 W, Overtable
(5) dark green curve: 300 W, Undertable
(6) pink curve: 600 W, Overtable
(7) red curve: 600 W, Undertable

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 9 Technical Specifications

9.1.3 Position of focus and Source-to-Image Distance (SID)

*Note: Source-to-Image Distance is also known as FOCAL SPOT TO IMAGE RECEPTOR DISTANCE
acc. to IEC60601-2-43:2010

9.1.4 Small focus (0.3) emission curves

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 9 Technical Specifications

9.1.5 Large focus (0.5) emission curves

9.1.6 Dose rate at the flat detector input

The dose rate is set at the factory; it is measured behind the anti-scatter grid at the flat
detector input. Refer to the acceptance protocol §115 StrlSchG for the system-specific
dose values (Federal Republic of Germany only).

The dose rate is set in the kV range between 70 and 80 kV using a technical phantom.

Dose rate value deviation

Depending on the examined object, different fluoroscopy data (kV, mA) arise. Because
flat detector sensitivity depends on beam quality (kV), the same gray values in the image
may correspond to different dose rate values at the detector input.

When examining a patient in fluoroscopy mode, additional scattered radiation values

are produced in comparison to the phantom values, affecting the dose rate at the flat
detector input.

Setting the dose rate value

If desired, the preferred position for the dose rate can be reprogrammed.

9.1.7 Fluoro curves

The following fluoro curve properties are available in the system for clinical use.

The following base values apply for all systems and fluoro curves:

• Minimum kV = 40

• Maximum kV = 125

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The currents (mA) shown in the following tables indicate effective values.

Systems with 25 kW generator

Characteristic curves for The maximum average power for normal fluoroscopy characteristic curves is 600 W.
fluoroscopy Characteristic curves with the HL add-on have a maximum average power of 1000 W
(limited to 30 s radiation), and curves with the HL ESU add-on have a maximum average
power of 3000 W (limited to 30 s radiation).

Example for the same object at 15 fpsa)

Characteristic Min mA (pulse) Max mA (pulse) kV ∅ mA (calcu‐ ∅ power (W)

Curve lated)

FL-CARD HP 3.0 59.5 80 4.0 320

FL-CARD HP HL 10.0 168.0 80 4.0 320

FL-CARD HP HL 10.0 200.0 80 4.0 320

ESU*

FL-CARD 3.0 42.2 80 4.0 320

FL-CARD HL 10.0 84.0 80 4.0 320

FL-CARD HL ESU* 10.0 84.0 80 4.0 320

FL-HC HP 3.0 67.0 69 8.0 552

FL-HC HP HL 10.0 224.0 66 9.5 627

FL-HC HP HL ESU* 10.0 250.0 63 12.0 756

FL-HC 3.0 53.1 71 6.6 469

FL-HC HL 10.0 100.0 66 9.5 627

FL-HC HL ESU* 10.0 100.0 63 12.0 756

FL-IOD HP 3.0 67.0 67 9.0 603

FL-IOD HP HL 10.0 211.5 66 9.5 627

FL-IOD HP HL ESU* 10.0 237.0 66 9.5 627

FL-IOD 3.0 50.1 66 8.9 590

FL-IOD HL 10.0 100.0 66 9.5 627

FL-IOD HL ESU* 10.0 100.0 66 9.5 627

FL-LD HP 3.0 56.0 92 2.3 212

FL-LD 3.0 37.6 92 2.3 212

FL-S HP 3.0 67.0 86 2.8 241

FL-S HP HL 10.0 211.5 78 4.5 351

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Example for the same object at 15 fpsa)

Characteristic Min mA (pulse) Max mA (pulse) kV ∅ mA (calcu‐ ∅ power (W)

Curve lated)

FL-S HP HL ESU* 10.0 250.0 71 7.2 512

FL-S 3.0 42.0 86 2.9 249

FL-S HL 10.0 100.0 78 4.5 351

FL-S HL ESU* 10.0 100.0 71 7.2 512

a) with the same image receptor dose

* only available on systems with the ESU option

Characteristic curves for

single image

Example for the same objecta)

Characteristic Curve Min mA (pulse) Max mA (pulse) kV mAs

DR-CARD HP 10.0 250.0 80 0.265

DR-CARD 10.0 100.0 80 0.265

DR-HC HP 10.0 250.0 67 0.594

DR-HC 10.0 100.0 67 0.600

DR-IOD HP 10.0 250.0 66 0.630

DR-IOD 10.0 100.0 66 0.630

DR-LD HP 10.0 250.0 83 0.223

DR-LD 10.0 100.0 83 0.223

DR-S HP 10.0 250.0 64 0.749

DR-S 10.0 100.0 64 0.750

a) with the same image receptor dose

Systems with 12 kW generator

Characteristic curves for The maximum average power for normal fluoroscopy characteristic curves is 600 W.
fluoroscopy Characteristic curves with the HL add-on have a maximum average power of 1000 W
(limited to 30 s radiation).

Example for the same object at 15 fpsa)

Characteristic curve Min mA (pulse) Max mA (pulse) kV ∅ mA (calcu‐ ∅ power (W)

lated)

FL-CARD HP 3.0 59.5 80 4.0 320

FL-CARD HP HL 10.0 119.0 80 4.0 320

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Example for the same object at 15 fpsa)

Characteristic curve Min mA (pulse) Max mA (pulse) kV ∅ mA (calcu‐ ∅ power (W)

lated)

FL-CARD 3.0 42.2 80 4.0 320

FL-CARD HL 10.0 84.0 80 4.0 320

FL-HC HP 3.0 67.0 69 8.0 552

FL-HC HP HL 10.0 119.0 66 9.5 627

FL-HC 3.0 53.1 71 6.6 469

FL-HC HL 10.0 100.0 66 9.5 627

FL-IOD HP 3.0 67.0 67 9.0 603

FL-IOD HP HL 10.0 119.0 66 9.5 627

FL-IOD 3.0 50.1 66 8.9 590

FL-IOD HL 10.0 100.0 66 9.5 627

FL-LD HP 3.0 56.0 92 2.3 212

FL-LD 3.0 37.6 92 2.3 212

FL-S HP 3.0 67.0 86 2.8 241

FL-S HP HL 10.0 119.0 78 4.5 351

FL-S 3.0 42.0 86 2.9 249

FL-S HL 10.0 100.0 78 4.5 351

a) with the same image receptor dose

Characteristic curves for

single image

Example for the same objecta)

Characteristic curve Min mA (pulse) Max mA (pulse) kV mAs

DR-CARD HP 10.0 150.0 80 0.265

DR-CARD 10.0 100.0 80 0.265

DR-HC HP 10.0 150.0 67 0.594

DR-HC 10.0 100.0 67 0.600

DR-IOD HP 10.0 150.0 66 0.630

DR-IOD 10.0 100.0 66 0.630

DR-LD HP 10.0 150.0 83 0.223

DR-LD 10.0 100.0 83 0.223

DR-S HP 10.0 150.0 64 0.749

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 9 Technical Specifications

Example for the same objecta)

Characteristic curve Min mA (pulse) Max mA (pulse) kV mAs

DR-S 10.0 100.0 64 0.750

a) with the same image receptor dose

9.1.8 Dosimetric information

Reference air kerma and reference air kerma rate

The REFERENCE AIR KERMA and REFERENCE AIR KERMA RATES were measured at a
distance of 30 cm (patient entry reference point) from the image receptor input with
a 20 cm PMMA phantom (equivalent to a typical patient) in accordance with IEC
60601-2-43:2010 +A1:2017+A2:2019, 203.5.2.4.5.102 and the content of Annex AA
“Particular guidance and rationale”.

Radioscopy, Detector size

20x20

Programa) Dose level U I tpulse Pulse rate Dose rate

with anti-scat‐ [kV] [mA] [ms] [1/s] [mGy/min]
ter grid

Intervention, low 63 61 5 7.5 3.2

Interv Standard
medium 67 67 5.2 15 8.2

high 65 119 5 15 13.2

Intervention, low 80 16 5 15 3.2

Interv Cardiac
medium 80 23 5 30 9.4

high 80 34 5 30 13.5

Intervention, low 63 61 5 7.5 3.1

Interv Gastro
medium 67 67 5.2 15 8.4

high 65 119 5 15 13.2

Intervention, low 80 16 5 7.5 1.6

Interv DSA Extr
medium 80 23 5 15 4.7

high 80 34 5 15 6.7

Intervention, low 80 15 5 7.5 1.6

Interv Abdomen
medium 80 23 5 15 4.6

high 80 34 5 15 6.6

Gastro, Gastro low 83 12 5 15 2.7

Standard
medium 86 15 5 30 7.6

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Programa) Dose level U I tpulse Pulse rate Dose rate

with anti-scat‐ [kV] [mA] [ms] [1/s] [mGy/min]
ter grid

high 89 19 5 30 10.3

Cardiac, Card low 80 14 5 15 2.9

Standard
medium 80 22 5 30 9.1

high 80 32 5 30 13.1

Vascular, Vasc low 63 60 5 7.5 3.1

Standard
medium 66 60 5.7 15 8

high 67 60 9.6 10 9.4

Urology, Uro low 63 60 5.1 7.5 3.1

Standard
medium 66 60 5.8 15 8.2

high 67 60 9.6 10 9.4

Ortho/Trauma, low 63 60 5.1 7.5 3.2

Ortho Standard
medium 66 60 5.8 15 8.1

high 67 60 9.7 10 9.4

General, Gen low 63 60 5.1 7.5 3.1

Standard
medium 66 60 5.7 15 7.9

high 67 60 9.7 10 9.5

General, Gen low 62 40 5 7.5 1.9

Adipose
medium 64 58 5 10 4.2

high 62 88 5 10 5.6

General, Gen low 66 60 9 7.5 6.4

Extremity
medium 69 57 10 15 15.6

high 76 52 10 15 17.5

General, Gen low 80 11 5 15 2.5

Standard HL
medium 80 33 5 15 6.5

high 80 72 5 15 14.3

General, Gen low 74 6.9 5 7.5 0.6

Pediatric, with‐
out grid medium 79 7.3 5 15 1.6

high 81 9 5 16 2.1

Intervention, high dose 125 53 5 30 55.9

Interv Cardiac

a) Only valid as delivered from factory. Technical changes reserved.

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Radioscopy, Detector size

30x30

Programa) Dose level U I tpulse Pulse rate Dose rate

with anti-scat‐ [kV] [mA] [ms] [1/s] [mGy/min]
ter grid

Intervention, low 62 48 5 7.5 2.3

Interv Standard
medium 65 54 5 15 5.7

high 64 90 5 15 9

Intervention, low 80 10 5 15 2.1

Interv Cardiac
medium 80 15 5 30 6

high 79 25 5 30 9.2

Intervention, low 63 49 5 7.5 2.3

Interv Gastro
medium 65 55 5 15 5.8

high 64 90 5 15 9.1

Intervention, low 80 11 5 7.5 1

Interv DSA Extr
medium 80 15 5 15 3.1

high 79 25 5 15 4.4

Intervention, low 80 10 5 7.5 1

Interv Abdomen
medium 80 15 5 15 3

high 79 25 5 15 4.5

Gastro, Gastro low 81 9.2 5 15 2

Standard
medium 84 11 5 30 5.4

high 86 15 5 30 7.2

Cardiac, Card low 80 10 5 15 2.1

Standard
medium 80 15 5 30 6.2

high 80 23 5 30 8.9

Vascular, Vasc low 62 47 5 7.5 2.2

Standard
medium 65 54 5 15 5.8

high 66 60 7.3 10 6.5

Urology, Uro low 62 47 5 7.5 2.2

Standard
medium 65 54 5 15 5.8

high 66 60 7.4 10 6.5

Ortho/Trauma, low 62 49 5 7.5 2.3

Ortho Standard
medium 65 54 5 15 5.8

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Programa) Dose level U I tpulse Pulse rate Dose rate

with anti-scat‐ [kV] [mA] [ms] [1/s] [mGy/min]
ter grid

high 66 60 7.4 10 6.6

General, Gen low 62 49 5 7.5 2.3

Standard
medium 65 54 5 15 5.8

high 66 60 7.5 10 6.6

General, Gen low 61 32 5 7.5 1.3

Adipose
medium 63 44 5 10 2.8

high 61 72 5 10 4.2

General, Gen low 66 60 6.2 7.5 4.1

Extremity
medium 66 60 8.5 15 11.6

high 69 57 10 15 14.5

General, Gen low 80 7.7 5 15 1.6

Standard HL
medium 80 23 5 15 4.3

high 80 50 5 15 9.1

General, Gen low 70 6.4 5 7.5 0.4

Pediatrics, with‐
out grid medium 74 6.9 5 15 1.1

high 78 7.3 5 15 1.4

Intervention, high dose 125 53 5 30 53.7

Interv Cardiac

a) Only valid as delivered from factory. Technical changes reserved.

Other pulse rates and zoom Dose values for other pulse rates and zoom factors may be roughly estimated with the
factors aid of the following scaling factors:

Pulse rate Scaling Factors for Air Kerma/Air

Kerma Ratea)
[1/s]
related to 15 p/s

0.5 0.03

1 0.07

2 0.13

3 0.2

5 0.33

7.5 0.50

10 0.67

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Pulse rate Scaling Factors for Air Kerma/Air

Kerma Ratea)
[1/s]
related to 15 p/s

15 1.00

30 2.00

a) Only valid as delivered from factory. Technical changes reserved.

Scaling Factors for Air Kerma/Air Kerma Ratea)

Zoom Steps 20x20 Detector 30x30 Detector

[Magnify]

0 1 1

1 1.33 1.5

2 2 2

a) Only valid as delivered from factory. Technical changes reserved.

Radiography, Detector size

20x20

Programa) Dose level U Q Exposure time Dose area prod‐ Dose

uct
[kV] [mAs] [ms] [mGy]
[μ Gym2]

Intervention, low 70.5 1.59 13.5 0.97 < 0.1

Interv Standard
medium 71.4 1.98 16.8 1.26 < 0.1

high 72 2.39 20.2 1.54 0.1

Intervention, low 79.9 0.86 7.4 0.74 < 0.1

Interv DSA Extr
medium 79.9 1.1 9.3 0.93 < 0.1

high 79.9 1.38 11.7 1.16 < 0.1

Intervention, low 80 0.82 7.1 0.70 < 0.1

Interv Abdomen
medium 79.9 1.09 9.3 0.92 < 0.1

high 80 1.34 11.5 1.14 < 0.1

Intervention, low 80 0.78 6.7 0.66 < 0.1

Interv Cardiac
medium 79.9 1.05 8.9 0.89 < 0.1

high 79.9 1.32 11.2 1.11 < 0.1

Intervention, low 70.5 1.57 13.3 0.97 < 0.1

Interv Gastro
medium 71.4 1.99 16.8 1.27 0.1

high 72 2.38 20.2 1.55 0.1

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Programa) Dose level U Q Exposure time Dose area prod‐ Dose

uct
[kV] [mAs] [ms] [mGy]
[μ Gym2]

Cardiac, Card low 79.9 1.38 11.7 1.11 < 0.1

Standard
medium 79.9 4.21 35.5 3.48 0.2

high 79.9 8.41 70.8 7.00 0.4

Gastro, Gastro low 87.6 0.92 9.4 0.93 < 0.1

Standard
medium 91.4 2.17 22.7 2.47 0.1

high 94.8 3.87 41.6 4.73 0.2

Vascular, Vasc low 72.2 2.23 23 1.45 0.1

Standard
medium 75.9 5.23 53.1 3.86 0.2

high 78.4 9.13 91.7 7.25 0.4

Urology, Uro low 72.2 2.2 22.7 1.44 0.1

Standard
medium 75.9 5.23 53.1 3.88 0.2

high 78.4 9.13 91.7 7.26 0.4

Ortho/Trauma, low 72.2 2.16 22.4 1.43 0.1

Ortho Standard
medium 75.9 5.23 53.1 3.87 0.2

high 78.4 9.14 91.7 7.26 0.4

General, Gen low 72.2 2.16 22.4 1.43 0.1

Standard
medium 75.9 5.22 53.1 3.88 0.2

high 78.4 9.13 91.7 7.26 0.4

General, Gen low 65.4 0.49 5 0.23 < 0.1

Adipose
medium 66.2 0.61 5.2 0.31 < 0.1

high 66.9 0.72 6 0.36 < 0.1

General, Gen low 65.9 4.6 47.3 2.41 0.1

Extremity
medium 74.2 13.15 149.6 9.13 0.4

high 90.7 10.58 149.6 11.67 0.6

General, Gen low 79.9 1.31 11.1 1.10 < 0.1

Standard HL
medium 79.9 3.95 33.5 3.32 0.2

high 79.9 8.03 67.8 6.73 0.4

General, Gen low 83.7 0.36 5 0.33 < 0.1

Pediatric with‐
out grid medium 87.3 0.93 9.4 0.95 < 0.1

high 90 1.68 17.3 1.86 0.1

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Programa) Dose level U Q Exposure time Dose area prod‐ Dose

uct
[kV] [mAs] [ms] [mGy]
[μ Gym2]

Intervention, high dose 124.9 7.93 105.9 16.71 0.8

Interv Cardiac

a) Only valid as delivered from factory. Technical changes reserved.

Radiography, Detector size

30x30

Programa) Dose level U Q Exposure time Dose area prod‐ Dose

uct
[kV] [mAs] [ms] [mGy]
[μ Gym2]

Intervention, low 69.5 1.1 5 1.26 < 0.1

Interv Standard
medium 70 1.28 5 1.50 < 0.1

high 70.7 1.47 6 1.87 < 0.1

Intervention, low 80 0.45 5 0.79 < 0.1

Interv DSA Extr
medium 80.1 0.57 5 0.98 < 0.1

high 80 0.72 5 1.23 < 0.1

Intervention, low 80 0.43 5 0.80 < 0.1

Interv Abdomen
medium 80 0.56 5 0.99 < 0.1

high 80 0.69 5 1.25 < 0.1

Intervention, low 80 0.43 5 0.79 < 0.1

Interv Cardiac
medium 80 0.56 5 0.98 < 0.1

high 80 0.69 5 1.25 < 0.1

Intervention, low 69.2 1.01 5 1.23 < 0.1

Interv Gastro
medium 70 1.21 5 1.48 < 0.1

high 70.5 1.42 5.8 1.81 0.1

Cardiac, Card low 80 0.70 5 1.26 < 0.1

Standard
medium 80 2.31 9.3 4.00 0.1

high 79.9 4.88 19.7 8.22 0.2

Gastro, Gastro low 85.4 0.51 5.2 1.07 < 0.1

Standard
medium 89.2 1.37 13.9 3.07 0.1

high 92.2 2.4 25.9 5.84 0.2

Vascular, Vasc low 70.8 1.44 14.7 1.85 < 0.1

Standard
medium 74.2 3.59 37 5.13 0.1

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Programa) Dose level U Q Exposure time Dose area prod‐ Dose

uct
[kV] [mAs] [ms] [mGy]
[μ Gym2]

high 76.7 6.32 64 9.55 0.2

Urology, Uro low 70.8 1.45 14.7 1.89 < 0.1

Standard
medium 74.2 3.6 37 5.13 0.1

high 76.7 6.33 64 9.56 0.2

Ortho/Trauma, low 70.8 1.45 14.7 1.89 < 0.1

Ortho Standard
medium 74.2 3.6 37 5.13 0.1

high 76.7 6.33 64 9.54 0.2

General, Gen low 70.9 1.45 14.7 1.85 < 0.1

Standard
medium 74.2 3.6 37 5.13 0.1

high 76.7 6.32 64 9.54 0.2

General, Gen low 69.2 1 5 1.23 < 0.1

Adipose
medium 69.9 1.24 5 1.52 < 0.1

high 70.5 1.48 5.7 1.79 < 0.1

General, Gen low 65.9 2.9 30 3.05 0.1

Extremity
medium 66.7 14.79 149.6 15.21 0.4

high 77.2 12.55 149.6 18.98 0.5

General, Stand‐ low 80 0.72 5 1.49 < 0.1

ard HL
medium 80 2.33 9.4 3.97 0.1

high 80 4.89 19.7 8.32 0.2

General, Pedia‐ low 81.9 0.22 5 0.43 < 0.1

tric, without
grid medium 85.7 0.6 6 1.24 < 0.1

high 88.2 1.09 11.1 2.35 0.1

Intervention, high dose 124.9 7.94 50.1 32.91 0.8

Interv Cardiac

a) Only valid as delivered from factory. Technical changes reserved.

DCM, Detector size 20x20 Exposure time for all measurements: 15s

Programa) Dose level U I tpulse Pulse Dose area Dose Dose rate
rate product
[kV] [mA] [ms] [mGy] [mGy/min]
[1/s] [μ Gym2]

Ortho/Trauma, low 62.4 100 5.6 7.5 27.10 1.4 5.5

Ortho Standard
DCM medium 65.8 100 6 15 68.84 3.4 14.1

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 9 Technical Specifications

Programa) Dose level U I tpulse Pulse Dose area Dose Dose rate
rate product
[kV] [mA] [ms] [mGy] [mGy/min]
[1/s] [μ Gym2]

high 67.2 100 9.7 10 79.87 4 16.3

Ortho/Trauma, low 55.2 24 5 10 5.93 0.3 1.1

Ortho Adipose
DCM medium 56 30 5 10 7.37 0.3 1.4

high 56.4 34 5 10 8.38 0.4 1.6

Ortho/Trauma, low 56 17 5 7.5 3.14 0.1 0.6

Ortho Spine
DCM medium 58.9 18 5 7.5 3.78 0.2 0.7

high 60.4 18 5 7.5 4.3 0.2 0.8

Ortho/Trauma, low 66 100 8.2 7.5 48.01 2.4 9.8

Ortho Extremity
DCM medium 66.9 99 10 15 120.64 6 24.7

high 75.2 87 10 15 145.35 7.3 29.8

Ortho/Trauma, low 65.8 100 9.4 7.5 54.90 2.8 11.2

Ortho Hand
DCM medium 68.2 97 10 15 125.96 6.3 25.8

high 77 84 10 15 148.91 7.5 30.5

Ortho/Trauma, low 66 20 5 7.5 6.39 0.4 1.2

Ortho Pediatric
DCM medium 70.7 22 5 15 16.9 0.9 3.3

high 76.2 24 5 15 22.08 1.1 4.5

a) Only valid as delivered from factory. Technical changes reserved.

DCM, Detector size 30x30 Exposure time for all measurements: 15s

Programa) Dose level U I tpulse Pulse Dose area Dose Dose rate
rate product
[kV] [mA] [ms] [mGy] [mGy/min]
[1/s] [μ Gym2]

Ortho/Trauma, low 73.4 23 5 7.5 18.86 0.4 1.8

Ortho Standard
DCM medium 78.4 25 5 15 48.63 1.2 4.8

high 81.2 32 5 15 66.18 1.6 6.5

Ortho/Trauma, low 56.8 51 5 10 25.70 0.6 2.5

Ortho Adipose
DCM medium 57.3 60 5 10 32.41 0.8 3.2

high 57.9 72 5 10 38.77 1 3.8

Ortho/Trauma, low 62.7 19 5 7.5 9.85 0.2 0.9

Ortho Spine
DCM medium 65 20 5 7.5 12.58 0.3 1.1

high 67.8 21 5 7.5 13.76 0.3 1.3

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 9 Technical Specifications

Programa) Dose level U I tpulse Pulse Dose area Dose Dose rate
rate product
[kV] [mA] [ms] [mGy] [mGy/min]
[1/s] [μ Gym2]

Ortho/Trauma, low 66 100 5 7.5 57.47 1.4 5.7

Ortho Extremity
DCM medium 66 100 6.4 15 149.69 3.7 14.9

high 65.9 100 11.2 15 260.44 6.4 26.1

Ortho/Trauma, low 66 100 5.3 7.5 61.75 1.6 6.1

Ortho Hand
DCM medium 66 100 6.9 15 157.26 3.9 15.7

high 65.9 100 12.1 15 276.85 6.8 27.7

Ortho/Trauma, low 61.4 19 5 7.5 9.82 0.3 0.9

Ortho Pediatry
DCM, without medium 64.9 20 5 15 25 0.6 2.4
grid
high 69.3 21 5 15 31.74 0.7 3.1

a) Only valid as delivered from factory. Technical changes reserved.

Dosimetric information in accordance to IEC

60601-2-43:2010
Measuring conditions • Specifications for interventional systems acc. to IEC 60601-2-43:2010

• REFERENCE AIR KERMA and ranges of REFERENCE AIR KERMA according to

IEC 60601-2-43:2010

Isokerma curves All following curves were recorded as follows:

beam projection horizontal and vertical (tube unit above)

• SID of 107 cm

• 25 cm x 25 cm x 25 cm PMMA Phantom centered/aligned central beam axis

• Entrance Surface of the Phantom is at the PATIENT ENTRANCE REFERENCE POINT

• Radiation field size 10 cm x 10 cm at entrance of PMMA Phantom

• Isokerma curves 100 cm and 150 cm above the floor

• STRAY RADIATION of isokerma curves in μGy/(Gy cm2) at 125 kV*)/20 mA and 15

pulses/s according to IEC 60601-2-43:2010
*)
NOMINAL X-RAY TUBE VOLTAGE acc. to IEC 60601-1-3:2008
+AMD1:2013 +AMD2:2021

The values in μGy/(μGy m2) according to IEC 60601-2-43:2000 can be calculated

by multiplying the given values in μGy/(Gy cm2) by a factor of 0.01. Subsequently
provided information relates to IEC60601-2-43:2010, 203.13 “Protection against
STRAY RADIATION” ff. and the conditions and methodology described in Annex BB
of IEC60601-2-43:2010.

The following diagrams show the isokerma curves of AIR KERMA DOSE and the
corresponding STRAY RADIATION in dependance of AIR KERMA DOSE AREA PRODUCT of
the primary X-RAY BEAM.

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 9 Technical Specifications

Cios Alpha, 100 cm above

floor, horizontal, Gy/(Gy cm2)

Cios Alpha, 100 cm above

floor, vertical, Gy/(Gy cm2)

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 9 Technical Specifications

Cios Alpha, 150 cm above

floor, horizontal, Gy/(Gy cm2)

Cios Alpha, 150 cm above

floor, vertical, Gy/(Gy cm2)

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 9 Technical Specifications

9.2 Precautions for EMC – 3rd Edition

According to the IEC 60601-2-54 Standard the product provides following /

Essential Performance

• Accuracy of Loading Factors

• Reproducibility of the Radiation output

• Automatic Control System

• Imaging performance

According to the IEC 60601-2-43 Standard the product provides following

Essential Performance

• Recovery management

• Radiation dose documentation

Medical electrical equipment needs special precautions regarding EMC. EMC

information provided in the accompanying documents must be followed
where appropriate.

Portable and mobile RF communications equipment can affect medical

electrical equipment.

Accessories, transducers and cables listed in this document do not affect the compliance
of the system according to IEC 60601-1-2:2007.

Fixed product cabling that cannot be removed by the user is not listed. This cabling is
part of the system and was considered in all EMC measurements. Without this cabling
the equipment or system would not function.

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
emission or decreased immunity of the equipment or system.

9.2.1 Guidelines and manufacturer's declaration – Electro‐

magnetic emissions
The system is intended for use in the electromagnetic environment as specified below.
The customer or the user of the system should ensure that it is operated in such
an environment.

Emissions test Compliance Electromagnetic environment

– Guidelines

RF emissions Group 1 The system uses RF energy exclusively

for its internal function. Therefore, its
according to CISPR 11
RF emissions are very low and not likely
to cause any interference in nearby
electronic equipment.

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Emissions test Compliance Electromagnetic environment

– Guidelines

RF emissions Class A The system is not suitable for use

in domestic establishments and estab‐
according to CISPR 11
lishments directly connected to a pub‐
lic power supply network that supplies
buildings used for domestic purposes.

Harmonic emissions Not applicable The system is not suitable for use
in domestic establishments and estab‐
according to IEC 61000-3-2
lishments directly connected to a pub‐
lic power supply network that supplies
buildings used for domestic purposes.

Voltage fluctuations/flicker Not applicable The system is not suitable for use
in domestic establishments and estab‐
according to IEC 61000-3-3
lishments directly connected to a pub‐
lic power supply network that supplies
buildings used for domestic purposes.

The use of this device or system can cause RF interference or interfere with the
operation of nearby equipment. In such cases employ suitable remedies such as
shielding or rearranging the equipment.

The system should not be operated next to or stacked with other equipment. If
adjacent or stacked use is necessary, the equipment or system should be observed to
verify normal operation in the configuration in which it will be used.

9.2.2 Guidelines and manufacturer's declaration – Electro‐

magnetic interference immunity
The system is intended for use in the electromagnetic environment as specified below.
The customer or the user of the system should ensure that it is operated in such
an environment.

The system complies with the Essential Performance Requirements according to

IEC 60601-1-2:2007.

Interference immun‐ IEC 60601 - test level Compliance level Electromagnetic environment – Guide‐
ity tests lines

Electrostatic dis‐ ± 6 kV contact discharge ± 6 kV contact discharge Floors should be made of wood, concrete
charge (ESD) or ceramic tiles. If the floor is covered with
± 8 kV air discharge ± 8 kV air discharge
synthetic materials, the relative humidity
IEC 61000-4-2
must be at least 30%.

Electrical fast transi‐ ± 2 kV for power sup‐ ± 2 kV for power sup‐ Power quality should correspond to that
ent/bursts ply lines ply lines of a typical commercial or hospital envi‐
ronment.
according to ± 1 kV for input/out‐ ± 1 kV for input/out‐
IEC 61000-4-4 put lines put lines

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 9 Technical Specifications

Interference immun‐ IEC 60601 - test level Compliance level Electromagnetic environment – Guide‐
ity tests lines

Surges ± 1 kV differential- ± 1 kV differential- Power quality should correspond to that

mode voltage mode voltage of a typical commercial or hospital envi‐
according to
ronment.
IEC 61000-4-5 ± 2 kV common- ± 2 kV common-
mode voltage mode voltage

Voltage dips, short inter‐ < 5% UT * (> 95% dip in < 5% UT * (> 95% dip in Power quality should correspond to
ruptions and fluctua‐ UT) for 0.5 cycles UT) for 0.5 cycles that of a typical commercial or hospi‐
tions of the power sup‐ tal environment. If the user of the sys‐
40% UT (60% dip in UT) 40% UT (60% dip in UT)
ply voltage tem requires continued operation during
for 5 cycles for 5 cycles
power mains interruptions, it is recom‐
according to
70% UT (30% dip in UT) 70% UT (30% dip in UT) mended that the system be powered from
IEC 61000-4-11
for 25 cycles for 25 cycles an uninterruptible power supply or a bat‐
tery.
< 5% UT (> 95% dip in UT) < 5% UT (> 95% dip in UT)
for 5 s for 5 s

Power frequency 3 A/m 3 A/m Power frequency magnetic fields should

(50/60 Hz) be at levels characteristic of a typical loca‐
tion in a commercial or hospital environ‐
Magnetic field according
ment.
to IEC 61000-4-8
* Remark: UT is the AC mains voltage prior to application of the test level.

9.2.3 Guidelines and manufacturer's declaration – Electro‐

magnetic interference immunity
The system is intended for use in the electromagnetic environment as specified below.
The customer or the user of the system should ensure that it is operated in such
an environment.

Interference immun‐ IEC 60601 - test level Compliance level Electromagnetic environment – Guide‐
ity tests lines

Portable and mobile RF telecommuni‐

cations equipment should be used no
closer to any part of the system (includ‐
ing cables) than the recommended sep‐
aration distance calculated from the
equation applicable to the frequency of
the transmitter.

Recommended separation distance

Conducted RF distur‐ 3 Vrms 10 Vrms

bances
150 kHz to 80 MHz
according to
IEC 61000-4-6

Radiated RF disturban‐ 3 V/m 10 V/m for 80 MHz to 800 MHz

ces
80 MHz to 2.5 GHz
according to
IEC 61000-4-3

for 800 MHz to 2.5 GHz

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 9 Technical Specifications

Interference immun‐ IEC 60601 - test level Compliance level Electromagnetic environment – Guide‐
ity tests lines

Where P is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter manufac‐
turer and d is the recommended separa‐
tion distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by electromagnetic site
surveya, should be less than the compli‐
ance level in each frequency range.b
Interference may occur in the vicinity
of equipment marked with the follow‐
ing symbol:

Remark 1: At 80 MHz and 800 MHz, the safe distance for the higher frequency range applies.

Remark 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Remark 3: For large and permanently-installed products according to the requirement 6.2.3.1 of IEC 60601-1-2:2007 the
product was tested for radiated RF immunity over the entire frequency range 80 MHz to 2.5 GHz

a 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 be
able to assess the electromagnetic environment with regard to the stationary transmitters, an electromagnetic site study
should be considered. If the measured field strength in the location in which the device or system is used exceeds the
applicable RF compliance level above, the device or system should be observed to verify normal operation. Should unusual
performance features be observed, additional measures (such as change in orientation or change of site of the system) may
be necessary.

b Above the frequency range of 150 kHz to 80 MHz the field strength should be less than 3 V/m.

9.2.4 Recommended separation distances between portable and

mobile RF telecommunications equipment and the system
The system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the operator of the system can contribute
to avoiding electromagnetic interference. For this purpose he should comply with the
minimum distance stated below (depending on the maximum output nominal power
of the communication devices) between portable and mobile RF telecommunication
devices (transmitters) and the system.

Rated maximum output Safe distance according to frequency of transmitter [m]

power of transmitter [W]

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

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Rated maximum output Safe distance according to frequency of transmitter [m]

power of transmitter [W]

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed in the table above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Remark 1: At 80 MHz and 800 MHz, the safe distance for the higher frequency range applies.

Remark 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

9.3 Precautions for EMC – 4th Edition

9.3.1 Declaration of immunity and emission compliance

The Cios Alpha complies with following test levels of IEC 60601-1-2:2014

Emission test: Baisc EMC standard or Compliance level:

test method:

Conducted and radiated CISPR11 Group 1, Class A

RF emissions

Immunity test: Baisc EMC standard or Compliance level:

test method:

Electrostatic discharge IEC 61000-4-2 ± 8 kV contact

± 2, 4, 8, 15 kV air

Electrical fast transi‐ IEC 61000-4-4 ± 2 kV for power supply lines; 100 kHz repetition frequency
ent / burst
± 1 kV for input / output lines; 100 kHz repetition frequency

Surge IEC 61000-4-5 ± 0.5, 1, 2 kV line to ground

± 0.5, 1 kV line to line

Voltage dips on power sup‐ IEC 61000-4-11 0 % UT for 0.5 cycle (1 phase)
ply lines
0 % UT for 1 cycle
70 % UT for 25/30 cycles (50/60 Hz)

Voltage interruptions on IEC 61000-4-11 0% UT; 250/300 cycles

power supply lines

Power frequency (50 or 60 IEC 61000-4-8 30 A/m

Hz) magnetic field

Conducted disturbances IEC 61000-4-6 150 kHz to 80 MHz: 3 Vrms

induced by RF fields
6 Vrms in ISM bands between 0.15 MHz and 80 MHz

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 9 Technical Specifications

Immunity test: Baisc EMC standard or Compliance level:

test method:

Radiated RF EM fields IEC 61000-4-3 80 MHz - 2.7 GHz: 3 V/m

Proximity fields from RF wire‐ IEC 61000-4-3 385 MHz: 27 V/m; Pulse modulation 18 Hz
less communications equip‐
450 MHz: 28 V/m; Frequency modulation ± 5 kHz deviation
ment
1 kHz sine
710, 745, 780 MHz: 9 V/m; Pulse modulation 217 Hz
810, 870, 930 MHz: 28 V/m; Pulse modulation 18 Hz
1720, 1845, 1970 MHz: 28 V/m; Pulse modulation 217 Hz
2450 MHz: 28 V/m; Pulse modulation 217 Hz
5240, 5500, 5785 MHz: 9 V/m; Pulse modulation 217 Hz

9.3.2 Declaration of EMC environment

The Cios Alpha is only suitable for professional healthcare facility environment according
IEC60601-1-2 ed. 4.

The system is not suitable for use in domestic establishments and establishments
directly connected to a public power supply network that supplies buildings used for
domestic purposes.

9.3.3 Adjacent or stacked equipment

Use of this equipment adjacent to or stacked with other equipment should be

avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operating normally.

9.3.4 List of cables, transducers and accessories

Fixed product cabling, which cannot be removed by the user, is not listed. This cabling is
part of the product and was present at all EMC-measurements. Without this cabling there
is no complete functionality of the product. Deviations or additions to this document are
added to the product-specific documents.

9.3.5 Usage of other accessories, cables and transducers

Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.

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 9 Technical Specifications

9.3.6 Portable RF communication 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 the
system including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.

9.3.7 Note for CISPR11 class A equipment

The emission 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.

9.3.8 Degradation and loss of the essential performance caused

by electromagnetic interferences

CAUTION

Electromagnetic interference of the system.

Degradation of the image quality or accuracy of the radiation parameters!

◆ Remove the source of interference (for instance, a mobile phone) from the area.
◆ Shut down the system and turn it on again.
◆ Pay attention to error messages during restart.

9.3.9 Instructions for maintaining basic safety and essential

performance with regard to electromagnetic disturbances
for the expected service life
Perform an annual visual inspection of accessible connectors, screws and conducting
cabinet door to ensure that its electrical connection has not deteriorated. In case of
any degradation call Siemens Healthineers Customer Service to replace or repair the
corresponding part. With this it is ensured that the design measures regarding to the
electromagnetic compatibility of the equipment remain effective during the whole
service life time.

9.3.10 Use of equipment nearby of emitters

This equipment has been tested for radiated RF immunity only at selected
frequencies; use of emitters in close proximity at other frequencies could result
in improper operation.

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 9 Technical Specifications

9.4 Original equipment manufacturer

Original Equipment Manufacturer (OEM), Open Source Software (OSS) from third-party
providers in Siemens Healthcare products.

9.4.1 Introduction
The product can contain OEM and OS software licensed and developed by third-party
providers (depending on the system configuration and options).

These OEM and/or OS files are protected by copyright. Your right to use OEM and/or OS
software beyond the mere execution of the Siemens Healthineers program is governed
by the relevant terms of the OEM and/or OS software license.

Complying with these licensing conditions authorizes you to use the OEM and/or
OS software as provided in the respective license. In case of conflicts between the
licensing conditions of Siemens Healthineers and the OEM and/or OS software license
conditions, the OEM and/or OS software conditions govern the OEM and/or OS portions
of the software.

The OEM and/or OS software licenses (license conditions) are available on the CDs/DVDs
(open source/legal concept) delivered together with the system.

9.4.2 For Open Source Software (OSS) only

Open source software is licensed free of charge (meaning that exercising the licensing
rights is free of charge, while fees may be charged to recover the costs borne by Siemens
Healthineers). If programs contained in this product are licensed under GNU General
Public License (GPL), GNU Lesser General Public License (LGPL), or another open source
license that requires source code, the corresponding code is delivered together with the
device on CD/DVD.

Warranty regarding the further use of software from third-party providers:

Siemens Healthineers makes no warranty regarding the OEM and/or OS software

programs in this device, when such programs are used in a manner other than
the program execution intended by Siemens Healthineers. The licenses mentioned
previously define the warranty, if any, from the authors or licensors of the OEM and/or OS
software. Siemens Healthineers specifically disclaims any warranties for defects caused
by altering any OEM and/or OS software program or the product’s configuration. If the
OEM and/or OS software violates the intellectual property of a third party, you have no
warranty claim against Siemens Healthineers.

Technical support is available only for software that has not been modified.

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 9 Technical Specifications

9.5 System data

9.5.1 Entire system

General data

Power requirements 100 V, 110 V, 120 V, 127 V, 200 V, 220 V, 230 V, 240 V (± 10%); 50/60 Hz (± 1 Hz)
An on-site 16 A/characteristic C overcurrent release (trip breaker) is recom‐
mended by DIN VDE 0100-710 for supply network voltages of 230 V/240 V.
Country-specific requirements apply for the fuse values to be used for other
supply network voltages.

Unit fuse protection (internal) 100 V to 127 V 20 A slow-blow fuse

200 V to 240 V 15 A slow-blow fuse

Nominal rating 20 A to 127 V∼, 15 A from 200 V∼ corresponds to the nominal value of the
slow-blow fuse in the power input of the product

Internal line impedance Ri max. 0.3 Ohm for 100 - 127 V∼

Ri max. 0.8 Ohm for 200 - 240 V∼

Power consumption Maximum 2.25 kW

Standby 713 W (for 230 V)

Continuous 20 A (100 V) / 10 A (230 V)

Short term 22 A (100 V) / 11 A (230 V)

Ambient conditions for operation Temperature range: +15 °C to +35 °C

and provisioning
Rel. humidity: 15% to 75%, non-condensing
Barometric pressure: 700 hPa to 1060 hPa

Ambient conditions for transport Temperature range: -20 °C to +70 °C

and storage
Rel. humidity: 10% to 95%, non-condensing
Barometric pressure: 700 hPa to 1060 hPa

For ambient conditions that fall within the specified values, no waiting time is required
for radiation operation.

At ambient conditions of 0 to +15°C and +35 to +50°C for transportation and storage,
a waiting time of 5 hours under ambient conditions for operation must be included.

At ambient conditions of -20 to 0°C and +50 to +70°C for transportation and storage,
a waiting time of 12 hours under ambient conditions for operation must be included
for radiation operation. In this case, the IQAP commissioning test must be carried out
for the device before using it.

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Weight

Monitor trolley 230 kg (including 2 monitors, UPS)

C-arm system Cios Alpha 12 kW Cios Alpha 25 kW Cios Alpha 25 kW ESU

352 kg 360 kg 374 kg

Additional weight for moto‐ 13 kg

rization

Classification

Protection against electric shock Class 1, no applied part according to IEC 60601-1

Protection against ingress of fluids IPX0 (not protected) according to IEC 60529

Operating mode Pulsed and continuous radioscopy

Current/voltage values

Voltage (V AC) Long-term current con‐ Short-term current con‐

sumption (A) sumption (A)

100 21 23
110 20 21
120 20 21
127 20 20
200 13 14
220 12 12
230 12 12
240 11 11

9.5.2 Generation of radiation

X-ray generator

The values in the table provide the technical thresholds of X-ray generation. Whether
these threshold values can be reached during clinical operation depends on the set
configuration values.

High-frequency generator 12 kW 25 kW 25 kW ESU

Nominal electric power 12 kW (100 kV, 120 mA, 25 kW (100 kV, 250 mA, 25 kW ESU (100 kV, 250 mA,
(IEC 60601-2-54) 100 ms) 100 ms) 100 ms)

Peak power output 15 kWa) 25 kW 25 kW

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Single image pulse 15 kW (100 kV, 150 mA, 25 kW (100 kV, 250 mA, 25 25 kW (100 kV, 250 mA, 38
power (max) 40 ms) ms; in service mode 100 ms) ms; in service mode 100 ms)

Average power in series 1000 W (e.g. 117 kV, 57 mA, 1000 W (e.g. 117 kV, 57 mA, 3000 W (e.g., 84.5 kV,
operation (max) 5 ms, 30 p/s) 5 ms, 30 p/s) 180.41 mA, 6.7 ms, 30 p/s)

Average power in series 1000 W (e.g. 117 kV, 57 mA, 1000 W (e.g. 117 kV, 57 mA, 4200 W (e.g. 83.3 kV, 163.1
operation (max) option DCM 5 ms, 30 p/s) 5 ms, 30 p/s) mA, 10.6 ms, 30 p/s)

Inverter control frequency 18 kHz to 50 kHz 18 kHz to 50 kHz 18 kHz to 50 kHz

kV range 40 kV to 125 kV 40 kV to 125 kV 40 kV to 125 kV

Single image 10 mA - 120 mA (peak power 10 mA - 250 mA 10 mA - 250 mA

150 mA)

0.05 mAs - 15 mAs 0.05 mAs - 15 mAs; in serv‐ 0.05 mAs - 15 mAs; in service
ice mode 25 mAs mode 25 mAs

5 ms - 150 ms pulse width 5 ms - 150 ms pulse width 5 ms - 150 ms pulse width

Fluoroscopy 3 mA - 119 mA 3 mA - 224 mA 3 mA - 250 mA

0.5 p/s up to 30 p/s 0.5 p/s up to 30 p/s 0.5 p/s up to 30 p/s

5 ms - 13 ms pulse width 5 ms - 13 ms pulse width 5 ms - 13 ms pulse width

Single tank heat stor‐ 1,900,000 J 1,900,000 J 1,900,000 J

age capacity
2,565,000 HU 2,565,000 HU 2,565,000 HU

a) not available in all countries

Data according to IEC

60601-2-54:

12 kW 25 kW 25 kW ESU

Radiography

Nominal X-ray tube voltage 125 kV @ Imax = 112 mA 125 kV @ Imax = 188 mA 125 kV @ Imax = 188 mA
@highest X-ray tube current

Highest X-ray tube current @ 150 mA @ Umax = 100 kV 250 mA @ Umax = 100 kV 250 mA @ Umax = 100 kV
Maximum X-ray tube voltage

Radioscopy

Nominal X-ray tube voltage 125 kV @ Imax = 94 mA 125 kV @ Imax = 106 mA 125 kV @ Imax = 126 mA
@highest X-ray tube current

Highest X-ray tube current @ 119 mA @ Umax = 99 kV 224 mA @ Umax = 62 kV 250 mA @ Umax = 64 kV
Maximum X-ray tube voltage

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Smallest value for current- 0.05 mAs

time product

Data according to Tube voltage (kV): ± 8%

IEC 60601-1-3:
Tube current (mA): ± 15% (minimum ± 0.1 mA)
Precision of the load‐
Current-time product (mAs): ± 10% (minimum ± 0.2 mAs)
ing parameters
Pulse duration (ms): ± 10% (minimum ± 1 ms)

X-ray tube assembly (Single-tank)

The X-ray tube assembly and image receptor are geometrically aligned such that
the emitted radiation cone (radiation axis) is always perpendicular to the plane of
the detector.

Model Single tank with dual-focus rotating anode tube

Nominal focus value (IEC 60336) 0.3/0.5

Tube rated voltage (IEC 613) 150 kV

Single tank rated voltage 125 kV

Target Material: Tungsten

Anode heat storage capacity (IEC 613) 270,000 J (365,000 HU)

Anode heat dissipation 70,000 J/min (91,000 HU/min)

Optical anode angle 10° (acc. to IEC 60366)

Inherent filtration tube (IEC 601) 3.0 mm Al with 75 kVp + 0.1mm Cu

Total filtration system (IEC 601) 3.0 mm Al (Monoblock) + 3.65 mm Al (0.1mm Cu) + 0.3 mmAl (DAP-chamber)
= 6.95 mm Al

Anode drive frequency up to 10,800 rpm (180 Hz)

Continuous heat dissipation 100 W without cooling, 300 W with cooling

(values apply for single tank alone without system environment)

Maximum irradiation time (with cool‐ 3 x 40 min at 500 W and 40 min pauses between the irradiation phases
ing option)
8 h at 250 W

Maximum irradiation time (without 8 h at 85 W

cooling option)

9.5.3 Image receptor

The Cios Alpha utilizes either a large or a small X-ray flat panel receptor with a scintillation
layer. This layer converts the incident X-rays into visible light, which is then absorbed in
the underlying photo diode. The measured signal is digitized and further processed in the
imaging system.

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Flat detector 20x20

Typical performance data of the detector is given in the following table.

Flat detector 20 cm x 20 cm (8" x 8")

CMOS (Complementary metal-oxide-semiconductor) flat detector based on indirect conversion technology

Input fields Mag 0 (full format) Mag 1 Mag 2

(active field) 20 cm x 20 cm 15 cm x 15 cm 10 cm x 10 cm

(8" x 8") (6" x 6") (4" x 4")

Material CMOS with CsI scintillator

Pixel size 152 μm

Matrix 1360 x 1360 pixel

Digitization depth 16 bit

Detective quantum effi‐ 75 %

ciency DQE (0), typi‐
cal, RQA5

Horizontal and vertical DQE, 57 % at 1 lp/mm

1μGy, RQA5, 1x1
41 % at 2 lp/mm

Modulation Transfer Func‐ 60 % at 1 lp/mm

tion (MTF), typical
27 % at 2 lp/mm

Anti-scatter grid (detacha‐ Pb 17 : 1, 70 lines/cm, f0 = 100 cm

ble)

Resolution on monitor with Overview (Mag 0) – acquisition (without zoom) 3.4 lp/mm
20 x 20 FD
Overview (Mag 0) – acquisition (with zoom) 3.4 lp/mm
(measured in accordance
with DIN 6868-150) Overview (Mag 0) – fluoroscopy 2.8 lp/mm

Format switchover (Mag 1) – acquisition 3.4 lp/mm

Format switchover (Mag 1) – fluoroscopy 2.8 lp/mm

Format switchover (Mag 2) – acquisition 3.4 lp/mm

Format switchover (Mag 2) – fluoroscopy 2.8 lp/mm

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Flat detector 30x30

Typical performance data of the detector is given in the following table.

Flat detector 30 cm x 30 cm (12" x 12")

CMOS (Complementary metal-oxide-semiconductor) flat detector based on indirect conversion technology

High-performance digital imaging system

Input fields Mag 0 (full format) Mag 1 Mag 2

(active field) 30 cm x 30 cm 20 cm x 20 cm 15 cm x 15 cm

(12" x 12") (8" x 8") (6" x 6")

Material CMOS with CsI scintillator

Pixel size 152 μm

Matrix 1952 x 1952 pixel

Digitization depth 16 bit

Detective quantum effi‐ 72 %

ciency DQE (0), typi‐
cal, RQA5

Horizontal and vertical DQE, 53 % at 1 lp/mm

1μGy, RQA5, 1x1
41 % at 2 lp/mm

Modulation Transfer Func‐ 58 % at 1 lp/mm

tion (MTF), typical
25 % at 2 lp/mm

Resolution on monitor with Overview (Mag 0) – acquisition (with zoom) 3.1 lp/mm
30 x 30 FD
Overview (Mag 0) – fluoroscopy 1.8 lp/mm
(measured in accordance
with DIN 6868-150) Format switchover (Mag 1) – acquisition 3.1 lp/mm

Format switchover (Mag 1) – fluoroscopy 2.8 lp/mm

Format switchover (Mag 2) – acquisition 3.1 lp/mm

Format switchover (Mag 2) – fluoroscopy 2.8 lp/mm

Anti-scatter grid (detacha‐ Pb 15 : 1, 80 lines/cm, f0 = 115 cm

ble)

9.5.4 Unit components

C-arm

Orbital movement 148° (-51.5° to +96.5°)

Motorized orbital movement (optional) 141° (-48° to +93°)

10°/s

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Angulation ± 225°

Motorized angulation (optional) ± 220°

10°/s

Horizontal movement 20 cm (7.9")

Immersion depth 73 cm (28.7")

Swivel range ± 12°

Vertical movement 45 cm (17.7"), motorized

Single tank image receptor distance 85 cm (33.5")

(patient opening)

SID 107 cm (42.1")

Collimator system

Rectangular collimator For concentric, radiation-free collimation

Slot collimator For symmetric and asymmetric radiation-free collimation, unlimited rotation

Imaging chain

Flat detector 20x20 1360 (H) x 1360 (V) @ up to 30 fps

Flat detector 30x30 1952 (H) x 1952 (V) @ up to 5 fps

1360 (H) x 1360 (V) @ up to 30 fps

976 (H) x 976 (V) @ up to 30 fps

Imaging System Features, e.g. digital image rotation ± 360°

Dose measuring chamber (DAP meter)

Attenuation equivalent (Inherent filtra‐ < 0.30 mm Al equivalent

tion)

Monitors
TFT high-brightness color
display

Screen diagonal 19" (48 cm)

Image display 1280 x 1024 (pixels)

Brightness (DICOM calibrated) 400 cd/m2

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Maximum brightness, typical 650 cd/m2

Horizontal/vertical viewing angle 178°/178°

Contrast ratio, typical 900 : 1

Technology Backlight LED

TFT Premium high-brightness

color display (optional)

Anti-reflexion coated cover Glass panel for higher-contrast image quality and easier cleaning

Brightness Uniformity Auto Adjustment Brightness uniformity is automatically adjusted for a more balanced and uniform
image impression

Automatic Brightness Adjustment Brightness is automatically adjusted based on ambient light

Automatic DICOM Correction DICOM curves are automatically corrected based on ambient light
(This feature greatly speeds up verification of conformity to DIN 6868-157 in
affected countries)

Full b/w emulation mode

Protective collision cover

Monitor Interface Input: 1 x DisplayPort

Screen diagonal 19" (48 cm)

Image display 1280 x 1024 (pixels)

Brightness (DICOM calibrated) 500 cd/m2

Maximum brightness, typical 1000 cd/m2

Horizontal/vertical viewing angle 170° / 170°

Contrast ratio, typical 1000 : 1

Response time, typical 25 ms

Backlight White LED technology

Monitor columns

Flex display column (Standard) Display positioning with rotation angle -30° to 210°; defined lock-in positions at
0º and 180º

Flex Plus display column (optional) Display positioning with rotation angle -30° to 210°; defined lock-in positions
at 0º, 90º and 180º, motorized height adjustment; fold function to protect the
displays in park position and during transport

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9.5.5 Equipment options

Detector laser light localizer (red)

Laser class Class 1 (IEC 60825-1:2014)

Laser type Semiconductor laser (laser diode)

Wave length 650 nm

Color Red

Effective power ≤ 4 mW

Detector laser light localizer (red, 1 mW)

For 30x30 flat detector, only:

Laser class Class 1 (IEC 60825-1:2014)

Laser type Semiconductor laser (laser diode)

Wave length 635 nm

Color Red

Effective power ≤ 1 mW

Single-tank laser light localizer (red)

Laser class Class 1 (IEC 60825-1:2014)

Laser type Semiconductor laser (laser diode)

Wave length 650 nm

Color Red

Max. power ≤ 4 mW

HD video manager

Outputs 2 x CAT (RJ 45); DVI-D via active CAT/DVI adapter; 1280 x 1024 @ 60 Hz

Inputs DVI-I (analog or digital) (2x), VGA with Adapter VGA to DVI-A, S-Video Mini-DIN
and BNC, Composite, SD/HD-SDI/3g-SDI (2x), HDMI 2.0 (2x), DisplayPort 1.2;
preprogrammed standard video timings up to (1920 x 1200, 50/60Hz, inter‐
laced/progressive) including PAL and NTSC DP and HDMI inputs provide video
timing up to 4K@60Hz

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DVI video splitter

Outputs 2 single-link DVI-D; female connectors; up to 1920 x 1200 @ 60 Hz or 1080 p

Conditions for use The displays or monitors used must be compatible with the SXGA standard 1280
x 1024 at 60 Hz
No galvanic separation, therefore the connected monitors must comply with
IEC 60601-1

WLAN access point

Option 1 Option 2

Ethernet transfer rate BASE-T max. 100 MBit/s 1487 Mbit/s

Wireless transfer rate max. 150 MBit/s 287Mbit/s (2.4GHz),

1201Mbit/s (5GHz)

Radiated power typically: 100 mW, max. 200 mW 2.4 GHz band: +20 dBm (17 dBm
per chain)
5 GHz band: +21 dBm (18 dBm
per chain)
Note: conducted transmit power levels
exclude antenna gain. For total (EIRP)
transmit power, add antenna gain

Supported wireless standards IEEE 802.11a IEEE 802.11a

IEEE 802.11b IEEE 802.11b
IEEE 802.11e IEEE 802.11g
IEEE 802.11g IEEE 802.11n
IEEE 802.11h IEEE 802.11h
IEEE 802.11i IEEE 802.11ac
IEEE 802.11n IEEE 802.11ax

Supported standards for power supply IEEE 802.3at Type 1 (802.3af) 802.3af POE (class 3)
and 802.3at Type 2 (power supply
via Ethernet)

Footswitch wireless

Data transfer Bluetooth BT4.1LT

Radiated power class 2: 2,5mW/ +4dBm transmission power

Supported wireless standards IEEE 802.15.1

Encryption Standard 128 bit AES-CCM

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Footswitch wireless receiver

Data transfer Bluetooth BT4.1LT

Radiated power class 2: 2,5mW/ +4dBm transmission power

Supported wireless standards IEEE 802.15.1

Encryption Standard 128 bit AES-CCM

9.6 Labels

This section provides information on the position of system labels. The numbers and
parameters on the labels are examples only. A real system label may contain other
numbers and parameters (such as the serial number).

9.6.1 C-arm system

The labels shown below are attached permanently to the following sub-assemblies.

(1) Base system (chassis)

(2) Horizontal support arm
(3) C-arm system control panel
(4) Control module for motorization package (optional)
(5) Anti-scatter grid
(6) C-arm inside
(7) Remote control unit (optional, not shown)

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Example of a MDD system identification label:

Example of a MDR system identification label:

(1) CONFIG: Configurable device

(2) MD: Medical device
(3) SN: Serial number
(4) UDI: Unique device identification

Example of a Approval-related label:

Example of a combination label:

Example of a system power label:

Depends on the power system of the order.

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1. Base system (Chassis)

General information

(1) Warning label read Operator Manual, transport park position, basic system

Hand switch

(2) Hand switch identification label

(3) Protection class label

Standard footswitch

(4) Standard footswitch identification label

Multifunctional footswitch

(5) Multifunctional footswitch identification label

Multifunctional footswitch,
wireless (optional)

(6) Wireless multifunctional footswitch identification labels

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2. Horizontal support arm

(1) Weight label

3. Control panel for C-arm system

(1) Manufacturer's identification label (left; right: alternative version)

4. Control module for the motorization package

(1) Manufacturer's identification label (left; right: alternative version)

5. Anti-scatter grid

(1) Manufacturer's identification labels (left; right: alternative version)

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6. C-arm inside
(*) various labels

(1) Example of a combination label

(2) Approval label

(3) Manufacturer's system identification label, approval label

X-ray tube unit

(1) Supplemental label

(2) Single tank identification label (left; right: alternative version)

(3) Approval label, filter label

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(4) X-ray tube identification label (left; right: alternative version)

Flat detector

(1) Supplemental label

(2) Flat detector identification label, approval label

Collimator

(1) Supplemental label

(2) Manufacturer's identification label for collimator (left; right: alternative version)

(3) Approval label

Dose measurement chamber

(1) Supplemental label

(2) Identification label

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(3) Approval label

Single-tank laser light

localizer (optional)

(1) Supplemental label

(2) Identification label

(3) Approval label

7. Remote control unit (optional)

(1) Manufacturer's identification label (left; right: alternative version)

(2) Protection class label

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9.6.2 Monitor trolley

(1) Manufacturer's identification label, approval label

(2) Monitor identification label

(3) Supplemental label country-specific connection data

(4) Approval label

(5) Approval label (not for China)

9.6.3 Pictograms
The following pictograms apply to your system.

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Pictogram Short description

Trolley plug

Plug-in port RCP (optional)

Hand switch

Foot switch

Equipotentiality

Injector trigger (optional)

Hot surface

Risk of crushing hand

Risk of crushing foot

Laser radiaton

Monitor transport

Read operator manual

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10 Options
10.1 Advanced Security Package to protect imaging system and patient data
(HIPAA) 333
10.1.1 Logging on to the system 333
10.1.2 Performing an emergency login 334
10.1.3 Changing the password 335
10.1.4 Changing an expiring password 336
10.2 Wireless WLAN network connection 337
10.2.1 Activating WLAN 337
10.2.2 Operation via Ethernet cable 338
10.3 Spacer 338
10.4 Cable for potential equalization 339
10.5 Multifunctional footswitch 339
10.5.1 Selecting the operating mode 339
10.5.2 Releasing radiation 340
10.5.3 Storing images (during radiation) 340
10.5.4 Storing images (after radiation) 340
10.5.5 Storage for transport 340
10.6 Multifunctional footswitch, wireless 341
10.6.1 Using the wireless multifunctional footswitch 342
10.6.2 Replacing the batteries 343
10.6.3 Storage for transport 344
10.7 Remote control unit 344
10.7.1 Remote control unit at the patient table 345
Attaching the remote control unit 345
Connecting the remote control unit 346
Removing the remote control unit and holder 347
Storing the remote control unit 347
10.7.2 Remote control unit cart 348
Adjusting the height of the remote control unit 349
Rotating the remote control unit 349
Tilting the remote control unit 350
Activating the remote control unit 350
10.8 Control module for the motorization package 350
10.8.1 Saving positions 350
10.9 Position memory for manual movements 351
10.9.1 Saving a position 351
10.9.2 Moving to the target position 351
10.9.3 Deleting the position memory 352
10.10 Sterile cover on the C-arm 352
10.10.1 Applying the sterile cover 353
10.11 Sterile cover for the remote control unit 355
10.12 Sterile cover for the remote control unit cart 355
10.13 Laser light localizer 356
10.13.1 Detector laser light localizer 356
10.13.2 Single-tank laser light localizer 356
10.13.3 Protection measures 356
10.14 Active cooling 357
10.15 Energy storage unit (ESU) 357
10.15.1 Reduction of acquisition kV for the same image receptor dose 357
10.15.2 Increased image receptor dose with the same kV 357
10.16 NaviLink 2D 357

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10.17 Connection for contrast agent injector 358

10.17.1 Description of interfaces 358
10.17.2 Connecting the Medtron injector to Cios Alpha 358
10.17.3 Connecting the Bayer injector to Cios Alpha 359
10.18 Video manager 360
10.19 DVI video splitter 361
10.20 "EMotion" sound system 361

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Anyone who connects additional equipment to the medical device is considered to

be configuring the system and is therefore responsible for ensuring that the current
system configuration complies with the relevant standards (e.g. system standard IEC
60601-1 and/or other applicable standards). In case of questions please speak with
your local contact person.

If one of the listed accessory parts requires special operating conditions (e.g.
temperature, air pressure, humidity), appropriate attention will be drawn to such
in the description. Please follow the Operator Manual provided by the manufacturer.

The following accessories have been approved for use with the Cios Alpha:

Accessories

Spacer

Grounding cable

Wireless network connection WLAN

Multifunctional footswitch

Multifunctional footswitch, wireless

Remote control unit

Holder for remote control unit

Remote control unit cart

Arterion Mark7 Interface cable Cios

Mark V ProVis Interface cable Cios

10.1 Advanced Security Package to protect imaging system and

patient data (HIPAA)
The HIPAA (Health Insurance Portability and Accountability Act) feature provides
mechanisms to secure the Cios Alpha imaging system, patient data and images from
misuse by unauthorized persons.

If HIPAA is licensed and activated, you must log-in using your login name and password.
Your system administrator must create user accounts and assign groups and privileges
to them. For more information concerning user management, please refer to the Cios
Alpha Administrator Manual.

10.1.1 Logging on to the system

After starting or restarting the system, the login window is displayed.

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1 Enter your login name and your password.

2 Click Login.

3 Confirm the window with the information regarding your last login.

The user interface of the Cios Alpha imaging system is displayed.

Depending on the rights given to a user by the administrator, not all patients can be
seen and some functions of the imaging system may not be available.

After a predefined maximum of unsuccessful login attempts the login for that user will
be disabled. Please contact your system administrator to re-enable your account.

10.1.2 Performing an emergency login

If you forgot your password or you do not have an account for this system and must
perform an emergency examination, you can perform an emergency login.

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◆ Click Emergency in the login window.

When logged-in as the emergency user, it is only possible to perform fluoroscopy

and acquisition. Only emergency patients can be seen. No other functions can be
performed and no other patients can be seen.

10.1.3 Changing the password

For the first login, the system administrator creates a login account with login name and
initial password.

1 Enter your login name and initial password.

2 Activate Change password after login and click Login.

The password change dialog is displayed.

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3 Enter your new password.

The rules for acceptable passwords are indicated in the window.

4 Re-enter your new password.

5 Confirm with Change.

10.1.4 Changing an expiring password

When your password will expire within the next 14 days, the password expiration
warning window is shown after you have logged in.

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◆ To change your password now: Enter the new password (twice) and click Change.
The rules for acceptable passwords are indicated in the window.

– or –

Click Skip to proceed without changing your password.

10.2 Wireless WLAN network connection

The WLAN option enables a wireless connection between the Cios Alpha and a (hospital)
network. The dedicated WLAN unit is integrated into the monitor trolley housing and is
completely set up. Its On/Off switch is found on the side of the monitor trolley.

(1) WLAN On/Off switch

10.2.1 Activating WLAN

◆ To activate WLAN, use the switch on the side of the monitor trolley.

The WLAN switch illuminates.

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Once the WLAN unit is switched on, it takes less than a minute for the WLAN
connection to be functional.

CAUTION

Interference.

Effect on persons with implants.

◆ Maintain a minimum distance in accordance with IEC 60601-1-2. If this is not

possible, switch off the WLAN client.

The coexistence of wireless sources operated in the same environment may affect the
quality of data transfer.

The transmission speed is reduced if additional WLAN clients are operated

simultaneously in the same environment.

For reasons of data security, it is recommended to encrypt the data in the WLAN
according to WPA or WPA2.

In case the wireless connection is interrupted, impaired or overloaded, it is

recommended to keep an Ethernet cable on hand, provided there are connection
options nearby.

If WLAN is activated, no devices sensitive to high frequencies should be placed on top

of the unit. Otherwise, damage to such devices or impairment to WLAN functionality
could result.

10.2.2 Operation via Ethernet cable

When operating the Cios Alpha via Ethernet cable, the WLAN at the monitor trolley needs
to be deactivated prior to switching on the system.

Simultaneous operation via Ethernet cable and WLAN is not possible and should be
avoided by all means.

After inadvertent simultaneous operation or after a change between both options, the
system must be switched off and on again.

10.3 Spacer
The distance between the source and tube assembly cover (focal spot - skin distance) is
≥ 200 mm with the standard system (according to IEC 60601-1-3:2008 + A1:2013).

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Country-specific regulations may require a larger source-skin distance (≥ 300 mm

according to DHHS 21 CFR). This is achieved by attaching an additional spacer to the
C-arm system.

◆ If this source-skin distance is too large for special examinations, the spacer can be
removed by taking off the screws.

The spacer must be reattached after this type of examination to ensure the reduction
in skin dose resulting from a greater source-skin distance.

10.4 Cable for potential equalization

A cable is available for potential equalization.

10.5 Multifunctional footswitch

10.5.1 Selecting the operating mode

The MODE (operating mode) button of the multifunctional footswitch allows you to
select one of the operating modes: Single image, fluoro, SUB, Roadmap or a video source
(depending on the configuration level).

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◆ If necessary, press this button on the multifunctional footswitch several times.

The selected operating mode is indicated in the Examination task card and on the
control panel of the C-arm system.

The set video source alters the image content of the right-hand monitor on the
monitor trolley.

A confirmation sound acknowledges successful operating mode/video source

switchover. You can then release radiation again right away.

10.5.2 Releasing radiation

The left pedal is always used to activate fluoroscopy (CFC) (Preferred setting).

The right pedal is used to activate the currently selected operating mode. Exception:
If Fluoroscopy (CFC) mode is selected, the right pedal is assigned the single image
operating mode.

The functionality of the pedals can optionally be changed.

◆ Keep the foot pedal pressed during radiation release.

10.5.3 Storing images (during radiation)

◆ Press the save button on the multifunctional footswitch during radiation.
The image currently generated and displayed is saved in the local database.

10.5.4 Storing images (after radiation)

◆ Press the save button on the multifunctional footswitch.
Holding the key for < 2 seconds: saves the image last recorded (LIH).

Holding the key for > 2 seconds: saves the scene last recorded (LSH).

The images are stored in the local database. They are transferred from the left monitor
to the right monitor unless the Hold reference function is active.

10.5.5 Storage for transport

To transport the multifunctional footswitch properly, proceed as follows:

◆ Insert the multifunctional footswitch and wrapped cable into the holder provided on
the front of the C-arm system.

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10.6 Multifunctional footswitch, wireless

The wireless multifunctional footswitch is identical to the wired version with respect to
functionality and operation. ( Page 339 Multifunctional footswitch)

(1) Rotary knob of battery compartment

(2) Operating mode button
(3) Stirrup for preventing unintended actuation
(4) Radiation release pedal for selected operating mode
(5) Radiation release pedal for fluoroscopy (Preferred setting)
(6) Battery status LED
(7) Connection status LED
(8) Save button for storing images or scenes

States of the status LEDs:

LED Subject Modes

Battery status LED Battery capacity Green: Battery full or nearly full
Orange: Battery almost full
Orange (flashing): Battery low

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LED Subject Modes

Connection sta‐ Radio link or pair‐ Green: Connection active

tus LED ing mode
Orange: No connection active
Orange (flashing): Footswitch not paired
Green and orange (alternately flashing):
Pairing mode activated

Battery status LED Fatal error or foot‐ Orange (both LEDs flashing): Fatal system
switch update errors (for example, battery exhausted or
and
memory error)
Connection sta‐
Green and orange (both LEDs alternately
tus LED
flashing): Firmware update process run‐
ning

The battery capacity is also shown on the monitor's status bar:

Symbol on status bar Battery capacity [%]

100 - 75

75 - 50

50 - 25

25 - 0

10.6.1 Using the wireless multifunctional footswitch

CAUTION

Radiation released from a footswitch in another room.

Non-clinical exposure to ionizing radiation.

◆ Make sure that the correct wireless footswitch is used by checking the label.

CAUTION

X-ray release may be possible from remote locations.

Unnecessary dose.

◆ Do not release X-ray if you are not in viewing distance to the patient.

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CAUTION

The wireless footswitch may be interfered by other equipment, including portable

and fixed RF communication equipment, even if such equipment meets the
applicable emissions requirements.

Fluoro or acquisition may sporadically be interrupted.

◆ The operator must assure that other wireless device in the 2,4 GHz ISM band
should not be operated in the vicinity of appr. 5m around the system.
◆ Please observe and verify normal operation of the wireless footswitch prior to
using it.

1 Take the wireless multifunctional footswitch out of the footswitch holder and place
it horizontally on the floor.

This will switch on the footswich, automatically.

2 Swivel the stirrup into the upright position until it locks.

The footswitch is now ready for use.

The multifunctional wireless footswitch automatically switches to standby mode if it

is not used for a certain period of time. It is activated again by actuating any button
or pedal.

10.6.2 Replacing the batteries

CAUTION

Weak batteries of wireless footswitch.

Delay in the clinical procedure.
◆ Make sure the batteries are charged prior to starting an examination.

1 To open the battery compartment on the bottom, lightly press in the knob and turn it.

2 Remove batteries.

3 Insert new batteries (LR14) into the wireless footswitch as shown in the diagram (see
arrow for insertion direction).

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4 To close the battery compartment, insert the knob into the depressions. Press lightly
and turn it until it clicks into place.

10.6.3 Storage for transport

To transport the wireless footswitch properly, proceed as follows:
◆ Insert the wireless footswitch into the holder provided on the front of the C-
arm system.

When inserting the wireless footswitch in the holder, make sure that the colored
symbols on the footswitch match the ones on the holder to avoid that the wrong
footswitch is inserted!

The following colored symbols are used for unique allocation of the footswitch to
the holder:

10.7 Remote control unit

The remote control unit allows the C-arm system to be operated in the OR directly from
different positions:

• From the patient table

• From the remote control unit cart

The remote control unit is used in the same way as the control unit on the C-arm system.

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CAUTION

The surfaces of the remote control unit become hot.

Risk of burns!

◆ Make sure that the patient does not touch the remote control unit for more than
10 minutes or that after 10 minutes can no longer come in contact with it.
◆ As a rule, contact between the patient and the remote control unit should
be avoided.

(1) Integrated EMERGENCY STOP button

(2) Displays and buttons of the remote control unit
(3) Control panel
(4) Control module for the motorization package

10.7.1 Remote control unit at the patient table

Attaching the remote control unit

CAUTION

Remote control unit falls down.

Risk of injury/crushing!

◆ It is recommended to keep the remote control unit in the holder provided. If a

holder is not available, place the remote control unit on the instrument table.

Attach the remote control unit to the patient table railing as follows:

1 Attach the holder to the table railing (1) and tighten the holder screw (2).

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2 Place the patient sterile cover over the holder.

3 If necessary, pack the remote control unit in the sterile cover and place it on the
magnetic holding plate.

CAUTION

Remote control unit covered by unsuitable covers.

Overheating of the remote control unit!

◆ Only use the sterile covers specified!

Connecting the remote control unit

(1) Round socket for connecting the remote control unit

◆ Plug the connector of the remote control unit into the round socket on the C-arm
system, which is located next to the central plug.

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The remote control unit is ready for operation and can be used in parallel with the
control panel on the C-arm system.

The remote control unit can also be connected to other C-arm systems. In this case a
message is displayed that you have to confirm.

Removing the remote control unit and holder

1 Unplug the connector of the remote control unit from the round socket on the
C-arm system.

2 Remove the remote control unit from the magnet by slightly tilting it to the side.

3 Remove the holder by first turning the screw (1) and then removing the holder
upward (2).

Storing the remote control unit

CAUTION

Improper positioning of the remote control unit.

Risk of contamination.

◆ Do not place the remote control unit on the patient.

To store the remote control unit, proceed as follows:

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1 Remove the remote control unit together with the holding plate from the table railing
and wrap the cable around the back.

2 Attach the remote control unit together with the holding plate to the monitor trolley
railing (see figures 1 and 2).

10.7.2 Remote control unit cart

The remote control unit is mounted on the cart. The cart can be moved in any direction
using the semicircular handle. Each of the 4 brakes can be used to park the cart.

(1) Remote control unit

(2) Cable holder
(3) Travel frame
(4) Wheels with brakes
(5) Handle for moving the cart

Use only this handle to move the trolley!

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Adjusting the height of the remote control unit

The remote control unit is height-adjustable. Proceed as follows to adjust the height:

Height adjustment (left: side view; right: rear view)

1 Turn the knob on the back of the cart column counterclockwise to release it.

2 Move the column up or down.

3 Secure the column at the required height by turning the knob clockwise.

Rotating the remote control unit

The remote control unit can be rotated. To do this, proceed as follows:

1 Open the lower lever of the swivel joint (1).

2 Turn the remote control unit to the left or to the right (2)

3 Secure remote control unit in the selected position by closing the lower lever (3).

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Tilting the remote control unit

The tilt angle of the remote control unit is adjustable. Proceed as follows to adjust it:

1 Open the upper lever of the swivel joint (1).

2 Set the tilt angle of the remote control unit (2)

3 Secure remote control unit in the selected position by closing the upper lever (3).

Activating the remote control unit

◆ Insert the cable of the remote control unit into the corresponding port on the
C-arm chassis.

10.8 Control module for the motorization package

The control module for the motorization package can be attached to the C-arm control
unit and to the remote control unit. It offers the user more efficient C-arm movements.

(1) Position memory

(2) Motorized C-arm movements
Yellow buttons: Angulating the C-arm
Blue buttons: Orbital movement of the C-arm

10.8.1 Saving positions

A maximum of two position memories can be used. Apart from the C-arm positions, the
current collimation settings will be stored.

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Use the same Magnification settings for both position memories. Otherwise, the
saved collimation settings can not be restored.

1 To save a position, move to the required C-arm position.

2 Then press the Save button.

The “Save position” buttons 1 and 2 both flash.

3 Select by pressing one of the two “Save position” buttons.

4 The “Save position” button then illuminates continuously to indicate that the position
was saved successfully.

5 To move the C-arm to the saved position, press and hold the button until the position
is reached.

At the same time, the collimators will be adjusted to the settings that have been
stored with positions 1 or 2.

When a new patient is registered, the position memory 1 will be reset to orbital 0° and
angular 0°.

10.9 Position memory for manual movements

With this function, the orbital and angular positions of the C-arm will be displayed on the
control panels and the left monitor. You can save an orbital and an angular position in the
position memory. After intermediate changes of acquisition position, this enables you to
move the C-arm back to the original position by hand.

10.9.1 Saving a position

1 Perform angular and orbital C-arm movement to a target position you want to save.

2 Press this button on the control unit.

The current orbital and angular positions are saved.

10.9.2 Moving to the target position

◆ Move the C-Arm toward the target position.
The required direction of movement and progress toward reaching the target
is indicated by corresponding icons on the control panel, see the following
example illustration:

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Icon Meaning

Deviation from target position > 5°

Deviation from target position < 5°

Deviation from target position < 1°

Target position reached precisely

On the left monitor, an arrow of the same color shows the deviation and the required
direction of movement during the examination.

10.9.3 Deleting the position memory

◆ Press the button in the activated state.

The position memory is deleted.

10.10 Sterile cover on the C-arm

To protect it against contamination, the C-arm including the flat detector and X-ray
tube assembly are completely covered with a three-piece sterile disposable cover of
transparent polythene sheet.

Do not use damaged sterile covers.

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C-arm completely covered

CAUTION

Improper attachment of the sterile cover on the C-arm.

Risk of infection!

◆ Follow the instructions for handling the sterile covers.

Always use sterile covers during interventions to protect the flat panel detector against
the ingress of liquids!

10.10.1 Applying the sterile cover

Follow these instructions to wrap the C-arm in the sterile cover:

1 Move the metal bracket into the transparent disposable cover.

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2 Tension the metal bracket with the disposable cover in the C-arm.

3 Pull the plastic cover over the single tank.

The plastic cover is fixed in place with an elastic cord.

4 Pull the other plastic cover over the flat detector.

5 Secure the plastic cover over the handle in the locations provided.

The C-arm is now covered completely.

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10.11 Sterile cover for the remote control unit

◆ Insert the remote control unit in the tube-like plastic sack and close it carefully.

10.12 Sterile cover for the remote control unit cart

Follow these instructions to wrap the remote control unit cart in the sterile cover:

1 Pull the sterile disposable cover over the cart with remote control unit.

(1) Front
(2) Back

2 Wind the adhesive strips tightly around the sterile disposable cover and attach
them firmly.

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The disposable cover is thus attached to the pillar of the cart.

10.13 Laser light localizer

10.13.1 Detector laser light localizer

To project the target crosshairs, two Class 1 lasers are used whose exit windows are
arranged in the detector cover.

10.13.2 Single-tank laser light localizer

To project the target crosshairs, two Class 1 lasers are used whose exit windows are
arranged in the single tank cover.

10.13.3 Protection measures

Brief exposure to a class 1 laser is safe for the eye.

The aversion response and the blinking reflex will usually protect the eye.

In Germany, the operator is responsible for ensuring that the user has been instructed in
the use of the laser. Outside Germany, the relevant laws and regulations regarding the
use of Class 1 lasers must be complied with.

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10.14 Active cooling

For a Cios system with a 12 kW generator, an additional active cooling system is available
as an option (standard for Cios systems with a 25 kW generator). The active cooling
system integrated in the single tank and C-arm ensures longer availability of the tube
assembly during extensive fluoro times, e.g. during complex OR procedures.

10.15 Energy storage unit (ESU)

For a system with a 25 kW generator, the “Energy Storage Unit” (ESU) function is available
as an option.

On the control panels, an ESU discharge status indicator is located at the top of the
exposure parameters area displaying the discharge in steps of 20%. It takes about one
minute for the ESU to recharge completely. Releasing radiation is possible before the
100% charging level is reached.

There are two supplemental applications compared to the normal 25 kW version.

10.15.1 Reduction of acquisition kV for the same image receptor

dose
This is recommended for example for obese patients when the power limit (mA) has
already been reached with normal fluoroscopy parameters. The reduction in kV usually
means a significant improvement in contrast.

10.15.2 Increased image receptor dose with the same kV

Improves the contrast-to-noise ratio for optimum display of the smallest structures.

If the highest selectable dose level per organ program selection is associated with
particularly high power, the corresponding button is called High level and marked
with a warning symbol. The maximum duration of a fluoro scene is limited to 30 s.

10.16 NaviLink 2D
If the NaviLink 2D option is available in the system and communication between the
navigation system and the C-arm is activated, you can see a NaviLink icon in the status
bar (bottom left) of the left monitor.

The navigation system sends a message to the C-arm system signaling readiness
for receiving images. The C-arm system receives the message, identifies the sending
navigation system and responds. The communication connection between the two
systems is activated and the NaviLink icon is displayed. As soon as the communication
connection is terminated, the NaviLink icon disappears again.

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10.17 Connection for contrast agent injector

A connection (unidirectional trigger output) for a contrast agent injector is possible as
an option.

The use of a contrast agent injector can result in an improved image quality during
subtraction angiography, since the stable flow rate of the contrast agent ensures
homogeneous contrast enhancement during the entire examination. This can also
reduce the patient's exposure to contrast agent and radiation.

Refer to the operator manual from the respective manufacturer for the operation and
start-up of the released contrast agent injector.

10.17.1 Description of interfaces

If the injector connected to this interface is in the armed state, Cios Alpha provides the
radiation on signal independent of the radiation mode (e.g. Fluoro, Sub/Road). This
signal is used by the injector to start the contrast agent injection.

Since the optimal point in time for the injection of contrast agent is right after the
subtraction mask has been created, it is recommended to set the delay on the injector
equal to the mask creation time, that is 2.6 seconds. The mask creation time in seconds
is displayed on the left monitor close to the subtraction mask progression bar.

CAUTION

Radiation release without contrast agent injection or unintended injection.

Risk of unnecessary radiation exposure or unintended contrast
agent injection.

◆ Make sure that the injector is ready to administer contrast agent before releasing
radiation. Note that every X-ray mode triggers the injector when it is in
ready state.

There are two injectors available for the Cios Alpha:

• Metron injector

• Bayer injector

10.17.2 Connecting the Medtron injector to Cios Alpha

1 Attach the contrast agent injector interface electronics housing to the Cios Alpha
electronics unit using the attachment kit provided.

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2 Insert the interface electronic housing connector into the corresponding Cios Alpha
electronics unit socket.

10.17.3 Connecting the Bayer injector to Cios Alpha

A system-specific connection cable is used for wired systems to connect the injector.

◆ Connect the Bayer injector interface cable to the corresponding Cios Alpha
electronics unit socket.

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10.18 Video manager

Cios Alpha has an additional HD video manager option for emitting video signals, e.g.
on external monitors, or for feeding in video signals for display on the reference monitor
(monitor B), e.g. for endoscopy images.

Only medical grade monitors must be connected.

The video signal feed interfaces are located on the back of the monitor trolley (see
left graphic).

To establish the connection to an external monitor, proceed as follows.

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1 Insert and secure the receiver module (1) in the DVI interface of your
external monitor.

2 Using a CAT cable (2), connect the receiver to the respective socket A (live monitor)
or socket B (reference monitor) on the monitor trolley.

3 Insert the 5 V connector of the power supply (3) into the receiver.

4 Plug the corresponding power plug into the power outlet.

The connection to the external monitor is now operational.

10.19 DVI video splitter

Cios Alpha has an additional DVI video splitter option available for outputting image
signals to an external live monitor (monitor A) and an external reference monitor
(monitor B) via the DVI connection.

Only medical grade monitors must be connected.

◆ To connect an external monitor, insert the DVI connection cable into the respective
interface for monitor A or B on the monitor trolley.

10.20 "EMotion" sound system

The EMotion integrated sound system is available as an option for Cios Alpha, with
an interface for operating external (MP3) audio equipment via Aux-in jack (Aux input)
including amplifiers with digital sound processor (DSP) and 2-way stereo loudspeaker
systems for high quality sound.

Do not connect a device with its own power cord to the Aux input, use battery-
operated devices only.

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 of the use of certain hazardous substances in electrical and electronic
equipment. Devices of the type Cios Alpha that comply with these
guidelines begin with the serial number from 40300 to 40999 and the
serial number starting from 42000.
Manufacturer’s notes: The CE marking applies only to Medical Devices which have been put
on the market according to the above-mentioned EU Regulation and EU
This device bears a CE mark in accordance with the provisions of
Directive.
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 Unauthorized changes to this product are not covered by the CE mark
restriction of the use of certain hazardous substances in electrical and and the related Declaration of Conformity.
electronic equipment. Devices of the type Cios Alpha that comply with
these guidelines have the serial numbers from 40000 to 40299 and Whenever the hardware necessary to run the software is supplied, the
from 41000 to 41999. CE Mark is provided in accordance with, if applicable, Electro Magnetic
Compatibility Directive 2004/108/EC and / or Low-Voltage Directive
This device bears a CE mark in accordonce with the provisions of EU 2006/95/EC.
Regulation 2017/745 of April 5, 2017 concerning medical devices and
the Council Directive 2011/65/EU of June 8, 2011 on the restriction Original language: English

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91052 Erlangen 91052 Erlangen
Germany Germany
Phone: +49 9131 84-0
siemens-healthineers.com

Published by Siemens Healthcare GmbH / Print No. ATSC-400.620.30.05.02 / © Siemens Healthcare GmbH, 09.2022