Siemens Healthcare MULTIX Impact C User manual

MULTIX Impact C
Operator Manual
VA21
siemens-healthineers.com

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Operator Manual
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Legend
Legend
Indicates a hint
Is used to provide information on how to avoid operating errors or information
emphasizing important details
Indicates the solution of a problem
Is used to provide troubleshooting information or answers to frequently asked ques‐
tions
Indicates a list item
Indicates a prerequisite
Is used for a condition that has to be ful󹪝lled before starting a particular operation
Indicates a one-step operation
Indicates steps within operating sequences
Italic Is used for references and for table or 󹪝gure titles
Is used to identify a link to related information as well as previous or next steps
Bold Is used for screen outputs of the system
Menu > Menu Item Is used for the navigation to a certain submenu entry
Text Is used to identify inputs you need to provide
Orange Is used to emphasize particularly important sections of the text
&$87,21
CAUTION
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
:$51,1*
WARNING
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 8
1.1 Intended purpose 8
1.1.1 Indications for use / Intended use 8
1.1.2 Contraindications 8
1.1.3 Clinical bene󹪝ts 8
1.1.4 Side e󹪜ects 9
1.1.5 Residual risks 9
1.1.6 Patient group 9
1.1.7 Physical functionality 9
1.1.8 Intended users 9
1.1.9 Conditions of use 9
1.1.10 Minimum requirements concerning hardware 9
1.1.11 IT network characteristics 10
1.1.12 Maintenance, cleaning, and disinfection 10
1.1.13 Service 10
1.1.14 Technical features 10
1.1.15 Frequently used operating functions 10
1.1.16 Operating functions regarding safety 10
1.2 Usability 10
1.3 Information about this Operator Manual 11
1.3.1 Area of application 11
1.3.2 Required documents 11
1.3.3 Operator Manuals on the internet 12
1.3.4 Pictograms 12
1.3.5 Names and parameters 12
1.3.6 Gender inclusivity 13
1.3.7 Illustrations 13
1.3.8 Value statements 13
2 System Safety 14
2.1 General safety information 14
2.1.1 User training 14
2.1.2 Laws and regulations 14
2.1.3 Explosion protection 16
2.1.4 Fire safety 16
2.1.5 Information about the software 17
2.1.6 IT-security statement 20
2.1.7 Checks, tests 20
2.1.8 Maintenance plan 21
2.1.9 Installation, repair or modi󹪝cations 26
2.1.10 Error messages and status indicators 27
2.2 Personal safety measures 27
2.2.1 Information about unit movements 27
2.2.2 Danger zones / danger points 33
2.2.3 Safety during patient examination 38
2.2.4 Radiation protection 41
2.3 Equipment safety measures 42
2.3.1 Protection against electric shock 42
2.3.2 Electromagnetic compatibility (EMC) 43
2.3.3 Safety-relevant parts subject to wear 44
2.3.4 Product service life 44
2.3.5 Mechanical safety 44
2.3.6 Combination with other products/components 47
2.3.7 Disposal 48

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Table of contents
2.3.8 Cleaning and disinfection 48
3 System Overview 54
3.1 Product description 54
3.1.1 Application capabilities 54
3.1.2 System con󹪝gurations 55
3.2 Basic system 55
3.2.1 System overview in the examination room 55
3.2.2 System overview in the control room 56
3.2.3 Image Station 56
3.2.4 Generator ON/OFF console 57
3.2.5 Unit overview 58
3.3 Ceiling-mounted tube support 59
3.3.1 Touch User Interface (TUI) 60
3.3.2 Multileaf collimator 68
3.4 Patient table 72
3.4.1 Application 72
3.4.2 Overview 72
3.4.3 Brake knob 73
3.4.4 Detector tray with wireless detector 74
3.4.5 Emergency STOP push button 74
3.4.6 Foot kick switches in the table base 74
3.5 Wall stand 75
3.5.1 Description 75
3.5.2 Application 76
3.5.3 Operating elements 76
3.5.4 Front panel markings 77
3.6 Wireless detectors (MAX wi-D or Core XL) 77
3.6.1 Description 77
3.6.2 Status and system messages 79
4 System Operation 81
4.1 On-O󹪜 81
4.1.1 Before using the system 81
4.1.2 Switching on a switched-o󹪜 system 81
4.1.3 Switching on after power failure or after an emergency SHUTDOWN
switch is activated 82
4.1.4 System switch-o󹪜 82
4.1.5 Emergency SHUTDOWN switch activation 82
4.1.6 Rebooting the system 83
4.1.7 UPS (for the imaging system) 83
4.2 Functional and safety check 88
4.2.1 Daily checks 88
4.2.2 Monthly checks 91
4.2.3 Functional check of the automatic systems 91
4.2.4 Checks concerning radiology 92
4.2.5 DAP display test 92
4.3 Preparation and movements of the overhead support 93
4.3.1 Directions for moving and rotating the tube 93
4.3.2 Directions for moving 93
4.3.3 Directions for rotating 93
4.3.4 Rotating the collimator 93
4.3.5 Positioning the 3D overhead support with tube unit 94
4.3.6 Tube tracking 97

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4.3.7 SID tracking 98
4.3.8 Deactivation of a tracking control 99
4.3.9 SID display 99
4.3.10 Rotating the multileaf collimator 99
4.4 Preparation and movements of the patient table 100
4.4.1 Collision protection 101
4.4.2 Adjusting table height 101
4.4.3 Positioning the tabletop 102
4.4.4 Inserting wireless detector 102
4.4.5 Positioning the detector tray 104
4.4.6 Scattered radiation grid 105
4.5 Preparation and movements of the wall stand 108
4.5.1 Safety information 108
4.5.2 Detector unit movements 109
4.5.3 Inserting the detector into the wall stand 110
4.5.4 Removing the detector 112
4.5.5 Scattered radiation grid 112
4.5.6 Positioning the tube unit automatically 114
4.5.7 Positioning the tube unit manually 114
4.5.8 Centering the tube unit in vertical direction 115
4.5.9 Centering the tube unit in horizontal direction 115
4.5.10 Moving the tube unit to the parking position 115
4.6 Preparation and handling of the wireless detectors 115
4.6.1 General safety information 115
4.6.2 Recommendations 116
4.6.3 Notes on handling the detector 117
4.6.4 Maintenance 120
4.6.5 Operation and setting of WLAN 120
4.6.6 Battery change (MAX wi-D) 122
4.6.7 Battery change (Core XL) 124
4.6.8 Charging the battery of the detector 125
4.6.9 FD management 126
4.6.10 Attaching the detector 127
4.6.11 Detaching the detector 128
4.6.12 Detector sharing with MAX wi-D 128
4.6.13 Detector calibration 128
4.7 Emergency operation 129
5 Examination 130
5.1 Safety information for examination 130
5.2 Positioning the patient on the table 131
5.2.1 Hygiene 131
5.2.2 Radiation protection 131
5.2.3 Grid and SID 131
5.2.4 Table position 131
5.2.5 Positioning very heavy patients 131
5.2.6 Tube unit position 132
5.2.7 Manual SID 132
5.2.8 Detector pulled-out 132
5.3 Positioning the patient at the wall stand 132
5.3.1 Hygiene 132
5.3.2 Radiation protection 132
5.3.3 Wireless detector 132
5.3.4 Grid 133

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Table of contents
5.3.5 Overhead patient hand grip 133
5.3.6 Tube unit position 133
5.3.7 Operating Height 133
5.4 IONTOMAT automatic exposure control 133
5.4.1 Performing IONTOMAT automatic exposure control 134
5.5 Additional Cu 󹪝lter 134
5.5.1 Selecting additional 󹪝lters 135
5.6 Light localizer and collimation 135
5.6.1 Switching on and o󹪜 of the light localizer 136
5.7 Collimation 137
5.7.1 Collimating manually 137
5.7.2 Collimation / Automatic Collimation Size Sensing 137
5.7.3 Restoring the last collimation 138
5.8 Exposures onto the patient table 138
5.8.1 Vertical projection onto the patient table 139
5.8.2 Vertical projection onto the pulled-out detector 140
5.8.3 Oblique projection onto the patient table 141
5.9 Exposures onto the wall stand 142
5.9.1 Horizontal projection onto the wall stand 142
5.9.2 Auto Thorax Collimation 143
5.9.3 Vertical projection onto the wall stand 143
5.9.4 Oblique projection onto the wall stand 144
5.10 Free exposure onto the wireless detector 145
5.10.1 Preparations 146
5.10.2 Positioning the tube unit 146
5.10.3 SID 146
5.10.4 Positioning for vertical projection 147
5.10.5 Positioning for oblique projection 147
5.10.6 Horizontal projection onto the mobile detector 147
5.11 Ortho operation 148
5.11.1 Ortho on patient table 148
5.11.2 Ortho on wall stand 148
5.11.3 Organ program for Ortho 149
5.11.4 Preparing Ortho 149
5.11.5 Releasing the Ortho exposures 155
5.12 Pediatric Use: Summary 156
5.12.1 Introduction 156
5.12.2 Use of anti-scatter grid 157
5.12.3 Use of 󹪝ltration 157
5.12.4 Automatic Exposure Control (AEC) 157
5.12.5 Speci󹪝c organ programs for pediatric examinations 158
5.12.6 Pediatric positioning aids 158
6 Accessories and Auxiliary Devices 159
6.1 Preliminary remarks 159
6.1.1 Equipment with accessories 159
6.1.2 Proper use of the product 159
6.1.3 Safety 160
6.1.4 Orientation 161
6.2 Description 161
6.2.1 Trolley UM mobile patient table 161
6.2.2 Patient positioning mattress 165
6.2.3 Paper roll holder 166
6.2.4 Hand grip strip 166

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Table of contents
6.2.5 Hand grip, lateral 168
6.2.6 Overhead patient hand grip 170
6.2.7 BABIX holder 172
6.2.8 Multipurpose / Ortho stand 173
6.2.9 Compression Belt 187
6.2.10 Cassette holder, lateral 194
6.2.11 Cassette holder without retainer 196
6.2.12 Mobile detector holder 197
6.2.13 Detector holder, lateral 198
6.2.14 Clip-on grids 200
6.2.15 FD protector 201
6.2.16 Wall holder for grids 202
6.2.17 Compensation 󹪝lters 202
6.2.18 Filter holder for eight 󹪝lters 206
6.2.19 Three-󹪝eld template, set 207
6.2.20 Wireless Remote Control Console 208
6.2.21 Foot switch 213
6.2.22 Battery charger (MAX wi-D) 214
6.2.23 Battery charger (Core XL) 216
6.2.24 Wall charger 217
6.2.25 Barcode scanner 218
6.2.26 Intercom system in control room 219
6.2.27 Smart Remote Control 219
7 Technical Description 220
7.1 Location of labels 220
7.1.1 Labels on the ceiling-mounted tube support 220
7.1.2 Labels on the tube unit with multileaf collimator 224
7.1.3 Labels on the wall stand 225
7.1.4 Labels on the patient table 227
7.1.5 Labels on the generator ON/OFF console 228
7.1.6 Labels on the generator cover 229
7.2 Technical data 230
7.2.1 System 230
7.2.2 Components 232
7.2.3 Network information 239
7.3 Notice concerning electromagnetic compatibility (EMC) 239
7.3.1 Guidance and manufacturer's declaration - electromagnetic emissions 241
7.3.2 Guidelines and manufacturer's declaration - electromagnetic immunity 241
7.3.3 Recommended separation distance between portable and mobile RF
communications equipment and the system 243
7.3.4 RF transmitters 244
8 Glossary 245
Index 246

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1 Introduction
1 Introduction
To operate the MULTIX Impact C system accurately and safely, the operating personnel
must have the necessary expertise as well as knowledge of the entire Operator Manual.
It must be read carefully prior to starting up the MULTIX Impact C system.
1.1 Intended purpose
Intended Purpose Statement under the European Medical Device
Regulation 2017/745:
Stationary X-ray system intended for various procedures that visualizes a variety of
anatomical structures.
1.1.1 Indications for use / Intended use
MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical
practices. MULTIX Impact C enables radiographic exposures of the whole body including:
skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric
patients. Exposures may be taken with the patient sitting, standing, or in the prone
position. MULTIX Impact C is not intended for mammography.
MULTIX Impact C uses digital detectors for generating diagnostic images by converting
X- rays into image signals. MULTIX Impact C is also designed to be used with conventional
󹪝lm/screen or Computed Radiography (CR) cassettes.
1.1.2 Contraindications
There are currently no known contraindications for MULTIX Impact C.
All residual risks are communicated to the user by warnings and cautions in the
operator manual.
The 󹪝nal 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 case involved.
Clinically relevant hazards and risks were mitigated as summarized in the risk
management report.
Clinically relevant side e󹪜ects and risks that are generally observed with the diagnostic
radiography and radiological technology and which are described in the literature, are
the exposition of the patients to intended ionizing radiation.
1.1.3 Clinical bene󹪝ts
The device is a digital X-ray system to generate X-ray images from the whole body
including the skull, chest, abdomen and extremities. The acquired images support
medical professionals to make diagnostic and/or therapeutic decisions. Generic clinical
bene󹪝ts of radiographic examinations within the intended use are applicable for
this device.

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1 Introduction
1.1.4 Side e󹪜ects
The side e󹪜ects of the device are derived from the risk analysis. Based on the clinical
evaluation, there are no known side e󹪜ects associated with the use of MULTIX Impact
C system.
1.1.5 Residual risks
Residual risks have been assessed and all relevant information is provided to the user via
this Operator Manual.
Please note that risks inherently connected to the use of this device (e.g. radiation or
moving parts) can not be avoided due to the nature of this device.
1.1.6 Patient group
The MULTIX Impact C system is designed for adult and pediatric (removable scattered
radiation grid) patients.
1.1.7 Physical functionality
The MULTIX Impact C system may be used for projection of radiographic examinations
of both adults and children (removable scattered radiation grid).
•On the patient table, X-rays can be taken on the recumbent or sitting patient from
head to foot. Exposures in the region of the skull, of the spine, of thorax, lungs and
abdomen as well as of the extremities are possible.
•On the wall stand, X-rays can be taken on the standing or sitting patient (chest, and
so on).
•In addition, exposures onto the wireless detectors in the form of free exposures
are possible.
1.1.8 Intended users
The MULTIX Impact C must be operated by quali󹪝ed personnel with the necessary
knowledge and expertise to operate X-ray equipment in accordance with the relevant
country speci󹪝c regulations.
( Page 14 User training)
1.1.9 Conditions of use
The system is suitable for medical facilities such as hospitals, doctor’s o󹪟ces, etc.
The climatic conditions speci󹪝ed in Technical data, Ambient conditions (operation) must
be complied with.
1.1.10 Minimum requirements concerning hardware
The MULTIX Impact C system 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
1.1.11 IT network characteristics
MULTIX Impact C may only be run in an environment approved or authorized by the
manufacturer. The system may not be operated in public networks without 󹪝rewalls
or isolation.
Refer to the “MULTIX Impact C Security White Paper and MDS2 Form”.
1.1.12 Maintenance, cleaning, and disinfection
Refer to ( Page 14 System Safety) and ( Page 81 System Operation).
1.1.13 Service
The service must only be performed by quali󹪝ed technical personnel.
1.1.14 Technical features
Refer to ( Page 230 Technical data).
1.1.15 Frequently used operating functions
Refer to ( Page 81 System Operation).
1.1.16 Operating functions regarding safety
Refer to ( Page 14 System Safety).
1.2 Usability
The systems must only be used by persons with the necessary specialist knowledge after
training, for example physicians, radiologists, cardiologists, and medical specialists.
•Patient population: newborn to geriatric.
•Operator pro󹪝le: The usage of the system described in this Operator Manual requires
speci󹪝c 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.
•Language understanding: Users must understand the language of the Operator
Manual before touching the system.
•Equipment training: Application training is supplied with the equipment according to
the hand-over contract. It is mandatory to follow such application training supplied 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
•Operator Manual and precautions: Read and understand all the instructions in the
Operator Manual before trying to use the system and request additional training from
Siemens Healthineers if necessary.
Keep the Operator Manual with the equipment at all times and periodically review the
procedures and safety precautions.
Failure to follow the Operator Manual and safety precautions could result in
serious injury to the patient, others or yourself.
•Patient safety: Give assistance for getting the patient on and o󹪜 the table. Be sure
all patient health lines (IV, oxygen, and so on) are positioned so they will not be
caught when moving the equipment. Never leave the patient unattended while in the
system room.
An unattended patient could fall from the table, start a movement control, or
encounter other problems which could be hazardous.
•Radiation safety: Always use correct technique factors for each procedure to minimize
X-ray exposure and to produce the best diagnostic results.
•Establish emergency procedures: It is not always possible to determine when some
components, such as X-ray tubes, are nearing the end of their operating lives. These
components could stop operating during a patient examination. Have an emergency
plan in case of non-availability of the system, for example, to use a di󹪜erent system.
CAUTION
Operation of the system by untrained users
Risk of incorrect diagnosis or treatment due to misinterpretation of
image information
◆The system must only be used by persons with the necessary specialist
knowledge, for example, physicians, trained radiologists, or trained
technologists, after an appropriate application training.
1.3 Information about this Operator Manual
To improve readability, your complete Operator Manual has been broken down into
several individual Operator Manuals with thematically distinct content:
•Operator Manual - MULTIX Impact C system
•Operator Manual - MULTIX Impact C imaging system
1.3.1 Area of application
This Operator Manual is valid for the following product:
•MULTIX Impact C (VA21)
1.3.2 Required documents
Reference is made in this Operator Manual to the following documents:
•Operator Manual - MULTIX Impact C imaging system

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1 Introduction
1.3.3 Operator Manuals on the internet
The electronic Operator Manuals for the system are available on the internet:
https://doclib.healthcare.siemens.com.
1.3.4 Pictograms
The following are pictograms and their meanings as they may apply to your system
(IEC standard).
Alternating current
Caution: Read Operator Manual
Caution: Laser
Pushing prohibited
O󹪜 (disconnection from line power supply)
On (connection to line voltage)
Attention: Hot surface (at the X-ray tube)
Degree of protection type B
1.3.5 Names and parameters
All names and data on patients and equipment that are used as examples in this Operator
Manual are entirely 󹪝ctional.
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 on your system are relevant.
The MULTIX Impact C may be shown with expanded equipment or with optional
accessories in some 󹪝gures.

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1 Introduction
1.3.6 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.
1.3.7 Illustrations
All illustrations of the equipment and of the user interface in this Operator Manual, are
examples only.
Di󹪜erences in detail may occur in your system due to the installed options, con󹪝guration
and constant development of the system.
Reproduction of images can cause loss of detail. Pictures in this Operator Manual do not
therefore provide any indication of image quality.
All names of patients in images or illustrations, are purely 󹪝ctional. Any similarities with
existing persons are entirely coincidental.
1.3.8 Value statements
All technical data are typical values unless speci󹪝c tolerances are stated.
Values in pictures of the software user interface, have no clinical meaning.
Only set the values preset in the exam sets provided or the values recommended by
experienced application specialists.

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2 System Safety
2 System Safety
2.1 General safety information
The organization responsible for the safety of the medical device according to IEC
60601 󹪜. is the user or the operator/operating company of the device.
2.1.1 User training
To operate the MULTIX Impact C system accurately and safely, the operating personnel
must have the necessary expertise as well as knowledge of the entire Operator Manual.
It must be read carefully prior to starting up the MULTIX Impact C system.
Application training is supplied with the equipment according to the hand-over contract.
It is mandatory to follow such application training supplied 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.
CAUTION
Operation of the system by untrained users
Risk of incorrect diagnosis or treatment due to misinterpretation of
image information
◆The system must only be used by persons with the necessary specialist
knowledge, for example, physicians, trained radiologists, or trained
technologists, after an appropriate application training.
2.1.2 Laws and regulations
The statutory regulations of the respective country must be followed.
If legally binding regulations govern the installation and/or the operation of the product,
it is the responsibility of the installer or the operator to observe these regulations.
Modifying the medical product is not permitted.
Country-speci󹪝c regulations
The legally established country-speci󹪝c regulations must be followed in all countries.
Deviating from this Operator Manual, values may be set according to country-
speci󹪝c regulations.

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2 System Safety
Incident reporting
Germany
Regulations in the EU
Due to the Medical Device Directive 93/42/EEC and EU regulation 2017/745 (MDR),
MULTIX Impact C complies with the standards of the IEC 60601-1 series.
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.
Additional national regulations
To ensure safety for operators, patients, and third parties, we recommend compliance
with the regulations listed here to the extent that local national laws allow.
RöV (X-ray Ordinance) - Legally required tests according to §16:
Before start-up
•Acceptance test
•Expert inspection
During operation
•According to the time intervals speci󹪝ed
Constancy test
MedBetreibV - Ordinance for system owners of medical equipment
•Safety check for technical construction at least every two years
Regulations in the USA and Canada
Corresponding to the Medical Device Directive in the EU, MULTIX Impact C complies in
the U.S.A. and Canada with the applicable standards.
Federal law stipulates that this system may only be sold to a physician or by order of
a physician.
Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure
factors, operating instructions and maintenance schedules are observed.
This system is intended for use in radiographic examinations and under the guidance of
a trained health care professional.
Handling of non RoHS spare parts
In the interests of preserving natural resources, Siemens Healthineers may recycle spare
parts which in some circumstances are not compliant with RoHS 2011/65/EU.
However, in these cases Siemens Healthineers uses the valid exemption to these
regulations which allow the use of these parts.

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2 System Safety
Data security
Personal data are subject to data protection.
•Please observe the relevant legal provisions.
Legally required tests
Legally required tests must be performed at the speci󹪝ed intervals.
These tests include, for example,
•Constancy test according to the X-ray ordinance (§16 RöV) in the Federal Republic
of Germany.
•Tests based on DHHS guidelines (Department of Health and Human Services)
where applicable.
For more detailed information refer to ( Page 88 Functional and safety check).
2.1.3 Explosion protection
MULTIX Impact C is not designed for operation in explosion-endangered areas.
CAUTION
The system is not designed for operation in explosion-endangered areas. It does
not ful󹪝ll the requirements for AP/APG classi󹪝cation.
Danger of explosion!
◆Do not use the system where explosive atmospheres can arise.
AP
Only products with the AP mark (AP = anesthetics test) may be used in explosion-
endangered areas
2.1.4 Fire safety
In the event of a 󹪝re, shut down the entire system immediately, that is, disconnect the
system from the main power supply.
1Press the emergency SHUTDOWN button or actuate the main or
disconnecting switch.
2Use a CO2 󹪝re extinguisher.
Do not use water!

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2 System Safety
CAUTION
Fire inside or in the vicinity of the system
Risk of injury of patient and personnel and damage to property. Risk of
inhalation of fumes from burning plastics.
◆Switch o󹪜 the system in the event of 󹪝re.
◆Help the patient to escape from the system.
◆Make sure that you know where the escape routes are.
◆Make sure that you know where the 󹪝re extinguishers are located and
familiarize yourself with the use of them.
3Contact Siemens Healthineers Customer Service before performing any refurbishing
work and before starting the system up again.
2.1.5 Information about the software
Network security
CAUTION
Unauthorized access to the system
Hazards up to and including loss of patient data and non-operational system
◆The hospital is responsible for network security at the site.
◆Set up user account password protections.
◆Do not allow users to change con󹪝guration 󹪝les.
Please note that the following are changes to the network that may introduce new risks:
•Network con󹪝guration change;
•Connection of additional systems or equipment to the network;
•Disconnection of systems or equipment from the network;
•Update or upgrade of equipment connected to the network.
Please note the following information relating to cybersecurity:
•Appropriate physical access controls shall be implemented;
•Cables shall be protected from interception, interference, and damage;
•Maintenance and inspection of devices shall only be carried out by
authorized personnel;
•External personnel who perform maintenance or service work shall be accompanied
at all times;
•Devices shall be secured with physical locking cables or securely locked away;
•The system shall lock down automatically or terminate the session after exceeding a
reasonable de󹪝ned idle time limit;

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•Applications shall log o󹪜 the user or terminate the session after exceeding a
reasonable de󹪝ned idle time limit;
•Malicious software shall not be created, downloaded, or distributed on purpose;
•User accounts shall only be assigned to and used by individual persons;
•For each account a di󹪜erent password shall be used;
•IP addresses assigned to systems shall be logged;
•Device log data shall be continuously analyzed;
•Device log data shall be stored for a reasonable time period;
•Devices shall be placed in network zones which ful󹪝ll and are appropriate for their
information security requirements;
•The system must be used by persons with necessary specialist knowledge after
training supplied by Siemens Healthineers Representative;
•The hospital is responsible for authorized access to the system;
•We recommend installing the system in a separate examination room with a
door controller;
•The system can be connected to the internal network. The hospital is responsible for
network security at the site;
•The Device Guard built into Windows 10 is used to prevent unauthenticated software
from being executed in the system;
•The 󹪝rewall built into Windows 10 is used to block network connections through
illegal ports;
•The security service is used to encrypt/decrypt important 󹪝les;
•The corespot service is used to enhance the security of the operating system;
•Normal users shall use a unique ID and password to log into the system;
•The system allows access in a special mode without authentication in order to enable
examination in the event of an emergency. For this special mode no password is set;
•The system has basic requirements on the length/complexity/expiry time of
the password;
•The system prede󹪝nes several user roles, and users can only access the functions
de󹪝ned in their roles;
•The system has been tested before its launch, making sure that there are no software
security vulnerabilities;
•The major 3rd party software used by the system has been registered to the Siemens
Healthineers SVM service to monitor security vulnerabilities that may be found
in future;
•Siemens Healthineers will analyze vulnerability noti󹪝cations from SVM in a timely
manner and take appropriate measures according to their severity;

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Introduction
For Open Source Software
(OSS) only
•Siemens Healthineers will provide timely patches or mitigations for serious software
security vulnerabilities;
•Siemens Healthineers releases a security patch for the system regularly (90 days) to
repair general security vulnerabilities.
Third-party software
Only software authorized by Siemens Healthineers for use with this product may
be used.
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 o󹪜ers control over when and who may make changes.
CAUTION
Use of unapproved or manipulated software or hardware components
Risk of malfunctions posing a hazard to patients and equipment
◆Only use software or hardware components approved by Siemens Healthineers.
◆Perform repairs only with our expressed written approval.
Original equipment manufacturer
Original Equipment Manufacturer (OEM), Open Source Software (OSS) from third-party
providers in Siemens Healthineers products
The product can contain OEM and OS software licensed and developed by third-party
providers (depending on the system con󹪝guration and option).
These OEM and/or OS 󹪝les 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 con󹪞icts 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 in the system.
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 available in the system.
Warranty regarding the further use of software from third-party providers:

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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 license mentioned previously
de󹪝ne the warranty, if any, from the authors or licensors of the OEM and/or OS software.
Siemens Healthineers speci󹪝cally disclaims any warranties for defects caused by altering
any OEM and/or OS software program or the product's con󹪝guration. 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 modi󹪝ed.
Copyright
The system and user software used in this product is copyright protected.
DICOM conformity
The digital imaging system is DICOM-conform. The “DICOM Conformance Statement”
is available on request from Siemens Healthineers or via the Siemens Healthineers
Internet homepage.
Remote software update
CAUTION
Software installation will disturb system functions.
Interruption of patient treatment and loss of patient data
◆Do not start installation during patient treatment.
CAUTION
Installation of the Update package failed.
Failed Software installation will result in an unde󹪝ned system state.
◆Do not use the system and call the Siemens Healthineers Service.
2.1.6 IT-security statement
The device can be connected to an IT-network. In this case, detailed information
regarding the combination and the risk caused by the combination are described in the
IT-security statement of accompanying documents.
2.1.7 Checks, tests
Before the system is used for examinations, the user must ensure that all safety-relevant
devices function correctly and that the system is ready for operation.
Important functional tests and checks must be made at certain time intervals.
( Page 88 Daily checks)