Siemens Healthineers SOMATOM User manual

siemens-healthineers.com
SOMATOM
Instructions for Use – Additional Product Information for China
X-ray Equipment for Computed Tomography

1 Introduction 5
1.1 Intended use 5
1.2 Compatible systems 5
1.3 Applicability 5
2Standards and electromagnetic
compatibility (EMC) 7
2.1 Standards according to IEC 60601-1, 3rd edition (China) 7
2.2 Electromagnetic compatibility according to
IEC 60601‑1‑2 8
2.2.1 Guidance and manufacturers declaration
on electromagnetic emissions 8
3NMPA registration number and Product
Technical Requirement (PTR) number 15
3.1 NMPA registration number 15
3.2 Product Technical Requirement number 15
4 Product labels for China 17
5 Radiation label for China 19
6RoHS labeling requirements for China 21
6.1 RoHS Labeling 21
6.2 Hazardous substances and elements 22
7 Released bolus injectors 25
8Released respiratory gating systems 27
9Restrictions regarding optional accessories 29
10 List of technical terms 31
11 SOMATOM Drive - Technical specifications 35
11.1 Typical CT conditions of operation 35
11.2 CT number (accuracy of CT values) 36
11.3 Image Noise 36
Table of contents
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
3

11.4 Uniformity (homogeneity for CT value) 37
11.5 Spatial resolution (high-contrast resolution) 37
11.6 Low-contrast resolution 38
12 Contact addresses for China 41
13 Structures and compositions 43
14 FAST 3D Camera 45
15 Restrictions regarding
syngo CT
postprocessing applications 47
Index 49
Table of contents
4Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02

Introduction
This document provides detailed information about the additional
product information for China.
Intended use
This computed tomography system is intended to generate
and process cross-sectional images of patients by computer
reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained
physician as an aid in diagnosis.
This product is used for the routine CT examination and supports
coronary CT angiography and energy-spectrum examinations.
Compatible systems
This information applies to the following CT system:
•SOMATOM Drive
Applicability
This manual is only valid in conjunction with the Instructions for Use
of each SOMATOM CT system.
1
1.1
1.2
1.3
Introduction 1
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
5

WARNING
Not observing the Instructions for Use and the safety
information of the medical device and the equipment!
Injury to the patient or personnel, and damage to the
equipment.
◆Always observe the Instructions for Use of the particular
units used. This includes the labels applied on the equipment
as well as the Instructions for Use documents.
◆Always use this Instructions for Use document in conjunction
with all Instructions for Use documents provided.
◆Follow the safety instructions and safety signs.
◆For references purposes, store the Instructions for Use near
your workplace.
1Introduction
6Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02

Standards and electro-
magnetic compatibility
(EMC)
The CT system and its components comply with the following major
standards.
Standards according to IEC 60601-1, 3rd
edition (China)
Standard Title
IEC 60601‑1:2012
GB 9706.1-2020
Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance
IEC 60601‑1‑3:2013
GB 9706.103-2020
Medical electrical equipment – Part 1-3:
General requirements for for basic safety and essential perform-
ance
Collateral standard: Radiation protection in diagnostic X-ray equip-
ment
IEC 60601‑2‑28:2017
GB 9706.228-2020
Medical electrical equipment – Part 2-28:
Particular requirements for the basic safety and essential perform-
ance of X-ray tube assemblies for medical diagnosis
IEC 60601‑2‑44:2016
GB 9706.244-2020
Medical electrical equipment – Part 2-44:
Particular requirements for the basic safety and essential perform-
ance of X-ray equipment for computed tomography
2
2.1
Standards and electromagnetic compatibility (EMC) 2
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
7

Standard Title
IEC 60601‑1‑2:2007
YY 9706.102-2021
Medical electrical equipment – Part 1-2:
General requirements for basic safety and essential performance
Collateral standard: Electromagnetic compatibility requirements
and tests
Electromagnetic compatibility according to
IEC 60601‑1‑2
Medical electrical equipment needs special precautions regarding
EMC and needs to be installed and put into service according to the
EMC information provided in the accompanying documents.
Portable and mobile radio frequence (RF) communications
equipment can affect medical electrical equipment.
Fixed equipment or system cabling, that cannot be removed by the
user, is not listed. The cabling is part of the CT system and present at
all EMC measurements.
The CT system without this cabling is not fully functional.
The use of accessories, transducers and cables other than those
specified may result in increased emission or decreased immunity of
the equipment or CT system.
Guidance and manufacturers declaration on electro-
magnetic emissions
CT systems are intended for use in the electromagnetic environment
specified below. The customer or the user of CT systems should
ensure that it is used in such an environment.
2.2
2.2.1
2 Standards and electromagnetic compatibility (EMC)
8Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02

Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11
GB 4824
Group 1 CT systems use RF energy only for its internal functions. Therefore, its
RF emissions are very low and are not likely to cause any interference
with nearby electronic equipment.
RF emissions CISPR 11
GB 4824
Class A CT systems are suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
GB 17625.1
Not applicable
Not applicable
CT systems have a rated input current of more than 16 A per phase.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
GB 17625.2
Not applicable
Not applicable
CT systems have a rated input current of more than 16 A per phase.
Declaration on electromagnetic emissions
The equipment or CT system should not be used adjacent to or
stacked with other equipment. If an adjacent use cannot be avoided,
you have to monitor the system to make sure the system is working
properly.
CT systems are intended for use in the electromagnetic environment
specified below. The customer or the user of CT systems should
ensure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance level Electromagnetic environment ‑ guidance
Electrostatic-
discharge (ESD)
IEC 61000-4-2
GB/T 17626.2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
GB/T 17626.4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
The quality requirement of the main power following a typical
commercial quality or hospital environment.
Guidance and manufacturers
declaration on electromagnetic
immunity
Standards and electromagnetic compatibility (EMC) 2
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
9

Immunity test IEC 60601 test
level
Compliance level Electromagnetic environment ‑ guidance
Surge
IEC 61000-4-5
GB/T 17626.5
± 1 kV line to line
± 2 kV line to
earth
± 1 kV line to line
± 2 kV line to
earth
The quality requirement of the main power following a typical
commercial quality or hospital environment.
Voltage dips,
short interrup-
tions, and volt-
age variations on
power supply
input lines
IEC 61000-4-11
GB/T 17626.11
< 5% UT (> 95%
dip in UT) for
0.5 cycle
40% UT (60% dip
in UT) for
5 cycles
70% UT (30% dip
in UT) for
25 cycles
< 5% UT (> 95%
dip in UT) for 5 s
Not applicable
< 5% UT (> 95%
dip in UT) for 5 s
The CT system has a rated input current of more than 16 A per
phase.
Power frequency
(50/60 Hz) mag-
netic field
IEC 61000-4-8
GB/T 17626.8
3 A/m 3 A/m Power frequency magnetic fields should be at levels character-
istic of a typical location in a typical commercial or hospital
environment.
Portable and mobile RF communications equipment should be
used no closer to any part of the CT systems, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
GB/T 17626.6
3 V 150 kHz – 80
MHz
3 V d=1.2√P
Radiated RF
IEC 61000-4-3
GB/T 17626.3
3 V/m 80 MHz –
2.5 GHz
3 V/m d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
2 Standards and electromagnetic compatibility (EMC)
10 Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02

Immunity test IEC 60601 test
level
Compliance level Electromagnetic environment ‑ guidance
[P] is the maximum output power rating of the transmitter in
watts [W] according to the transmitter manufacturer and [d]
is the recommended separation distance in meters [m]. Field
strengths from fixed RF transmitters, as determined by an elec-
tromagnetic site survey,
a) should be less than the compliance level in each frequency
range.
b) Interference may occur in the vicinity of equipment marked
with the following symbol:
Declaration on electromagnetic immunity
UT is the a.c. mains voltage prior to application of the test level.
At 80 MHz and 800 MHz, the higher frequency range applies.
Standards and electromagnetic compatibility (EMC) 2
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
11

These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
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 assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered.
If the measured field strength at the site of a CT system exceeds
the applicable RF compliance level above, the CT system should
be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting
of the CT system.
b: Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than 3 V/m.
CT systems are intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer
or the user of CT systems can help prevent electro magnetic
interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the CT
systems as recommended below, according to the maximum output
power of the communication equipment.
Minimum distance between RF communication equipment
Rated maximum output
power of transmitter [W]
Separation distance according to frequency of transmitter [m]
150 kHz to 80 MHz
d=1.2√P
80 MHz to 800 MHz
d=1.2√P
800 MHz to 2.5 GHz
d=2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
Recommended separation
distances between portable
and mobile RF communications
equipment and the CT system
2 Standards and electromagnetic compatibility (EMC)
12 Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02

For transmitters rated at a maximum output power not listed
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.
At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects, and people.
The CT system provides the option for intentionally receiving and
transmitting RF electromagnetic energy for the purpose of the
operation. The CT system that includes RF transmitters is labeled
with symbol no. 5140 for non-ionizing radiation of the IEC 60417-DB-
HS published.
Accompanying information:
Frequency: 2402 – 2480 MHz (79 channels)
Modulation: Gaussian Frequency Shift Keying (GFSK)
Maximum permitted
power:
according to Class 2, 2.5 mW (4 dBm)
Range: ~10 m
Recommended separation distances between portable and mobile
RF communications equipment and the CT system.
CT systems are intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or
the user of CT systems can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the CT systems as
recommended below, according to the maximum output power of
the communication equipment.
Receiving and transmitting RF
electromagnetic energy
Standards and electromagnetic compatibility (EMC) 2
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
13

Other equipment may interfere with the medical equipment, even if
the other equipment complies with CISPR emission requirements.
2 Standards and electromagnetic compatibility (EMC)
14 Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02

NMPA registration number
and Product Technical
Requirement (PTR)
number
This chapter introduces the NMPA registration number and the PTR
number for SOMATOM systems.
NMPA registration number
This section shows the NMPA registration number for the SOMATOM
system.
SOMATOM Drive
Product Technical Requirement number
This section shows the PTR number for the SOMATOM system.
SOMATOM Drive
3
3.1
3.2
NMPA registration number and Product Technical Requirement
(PTR) number 3
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
15

3NMPA registration number and Product Technical Requirement
(PTR) number
16 Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02

Product labels for China
In this chapter, you find the product labels for China. The labels
shown here are examples only.
Medical device label
(1)
Expected service life label
SOMATOM CT systems 系统预期安全使用的期限为 10 年 根据
IEC60601-1:2005 要求). 请注意，为了保证系统在 此期限内的安全
使用，应遵守本手册中所规定的强制性安全检查及其时间间隔要
求；且适当时应采取预防性 措施或进行维修
The SOMATOM CT systems are specified for an Expected Service Life
of 10 years for which the systems are expected to be safe for use
(according to IEC 60601-1:2005).
Note that the safety checks and their time intervals, as specified in
the System Owner Manual, are mandatory.
4
Product labels for China 4
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
17

Where appropriate, preventive measures have to be adopted or
repairs performed to ensure the safety of the system for this time.
4 Product labels for China
18 Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02

Radiation label for China
An additional label is placed on the gantry rear side of your CT
system.
The location of the label is depicted in the schematic representation
of the equipment.
(1) Warning label: radioactive material or ionizing radiation
Warning; Radioactive material or ionizing radiation
To warn of radioactive material or ionizing radiation.
5
Radiation label for China 5
SOMATOM | X-ray Equipment for Computed Tomography
Print No. C2-047.623.07.08.02
19

5 Radiation label for China
20 Additional Product Information for China | Instructions for Use
Print No. C2-047.623.07.08.02