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Technical Manual
BTI-050
Magnetic Resonance Imaging System
Version: A4
Foreword
The system(BTI-050 magnetic resonance imaging system) include the operation manual,
technical manual and maintenance manual. This manual is technical manual.
The operators, doctors, MR workers and other persons concerned must know and observe
local relevant medical apparatus and instruments law and regulations before using BTI-050
MRI system.
The operators, doctors, MR workers and other persons concerned must read This manual, be
familiar with the relevant data，and know about the equipment performance.
BTI-050 MRI system must be operated by trained and qualified persons strictly according to
This manual. Any problem must be reported to our trained qualified serviceman or our
engineer for service. Otherwise, our company will not assume any responsibility caused by
this.
Warning: do not modify this equipment without authorization of the manufacturer.
Due to continual updating of technology, some detail in This manual may different from the
actual conditions of the product BTI-050 MRI system. Please be assured to refer to our
up-to-date explanation.
Product name: Magnetic Resonance Imaging System

Model: BTI-050
Manufacturer: Shenzhen Basda Medical Apparatus Co., Ltd.
After-sales service: Shenzhen Basda Medical Apparatus Co., Ltd.
Address: 1B, Basda Medical Device Building, No. 28 Nantong Road, Baolong Street, Baolong
Community, Longgang District, 518116, Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Tel: +86 755 89686018
Fax: +86 755 89686918
Email: info@basda.com.cn
Website: www.basda.com.cn
Service Hotline: 4006000815
European Representative: Shanghai International Holding Corp. GmbH (Europe)
Address: EIFFESTRASSE 80, 20537 Hamburg, Germany
Basda Magnetic Resonance Imaging System

Safety Warning
1. This system shall not be serviced or maintained while in use with the patient.
2. For the safety of patients and the persons concerned, use hearing protection device when
necessary.
3. Other hospital devices can be influenced when approaching the magnetic field and the MRI
image quality is likely to be influenced by these devices.
4. Metal implant may generate evocation electric current and be heated so that patients bearing
implant are not allowed to take scanning.
5. Must setup warning sign of protected area at the entrance of the scanning room.
6. Warning, if incorrect replacement, it may result in a unacceptable risk, such as electric shock,
degradation of performance ect.
7. Do not change the installation order.
8. Please check the date and time of the operating system, and make them consistent with current
time.
9. Scanning room lighting may bring interference to image! It is recommended to replace the
filament lamp regularly.
10. Please use Basda MRI system CD provided by Basda.
11. The load bearing and stress analyses of the scanning room construction is ensured. It is suggested
to evaluate it fully by relevant organizations.
12. The receiving coil contacts with patients frequently, to avoid cross infection，it is necessary to
rinse or wipe the coil with 75% alcohol. Water or other cleaning solution is not suitable in
cleaning!
13. Be cautious to restrict the exposing time for patients as per local regulations on exposition in
magnetic field.
14. During scanning, gradient coil changes magnetic field quickly, which may cause stimulation on
peripheral nerves or tingling on some patients. To reduce possibility of peripheral nerve irritation,
please ensure the patient will not hold or touch their hands, nor cross their feet to avoid forming a
conductor return circuit.
15. Radio frequency will happen during scanning, which may lead to the following hazard: Tissue
heating, Magnetic hole heating, Contact point heating, Metal object heating, Cable/conductor
heating
16. In the scanning room, there must no iron oxygen bomb, iron wheelchair, iron gurney, iron IV
(intravenous transfusion) steeve, iron ventilator and others. Make any people approaching to MRI
system know that only nonferrous objects can be allowed to enter the scanning room，at the same
time set up regulations describing carrying medical devices and others into the scanning room.
17. The use of accessories, transducers and cables other than those specified with the exception of
transducers and cables sold by your company as replacement parts for internal components, may
result in increased emission or decreased immunity of the Magnetic Resonance Imaging System
18. Air conditioner and automatic constant temperature system shall be 24 hour work. The air
conditioner must be turned on in time when power restored after failure and the operating settings
need to be confirmed in correctness. The knockoff of air conditioner and automatic constant
temperature system in a short time may influence state of the system at the moment.
19. Other system's signal input/output can only connect with the pointed equipment. Users should get
our confirmation before connecting them to other devices and follow the Provision IEC601-1-1.
20. Safety of magnetic resonance scanning on fetus and children has not been proved yet. Before
control the harm of scanning on patients, please weight the conflict of interest between magnetic
resonance and the other alternative procedures and let the doctor decide if the pregnant woman or
children patients should take scanning or not.
21. There might be projecting effect around magnetic field. To prevent threat to magnet and personal
safety from ferromagnetic projectiles, the transportation of magnet should be handled or
instructed by our technicians. Please read closely the relevant safety notice.
22. Magnet weight is 27000Kg at least; please note the reliability of lifting tools. And the base
strength for magnetic body should be affirmed in advance!
For your safety and the patients’ safety as well as the safety of device, be sure to follow the
requirements of “Safety Warning”.
Danger and prohibition Symbols & signs used in MRI installations
Figure
Item Meaning
Symbol etc.
Warning sign
1
Warning, risk of strong magnetic field
Warning sign
2
Warning, risk of non-ionizing radiation
Prohibition sign
3
No access for person with pacemaker
Prohibition sign
4
No access with metallic pieces or watches
Prohibition sign
5
No access for person with metal implants
6 General warning sign
7 Follow instructions for use
8 Type B applied part

9 Protective earth(ground)
10 Earth(ground)
11 “ON”(power)
12 “OFF”(power)
13 Alternating current
14 Date of manufacture
15 Manufacturer
Authorized representative in the European

16
Community
CE marking, “xxx” is the code of CE notified

17
body
xxx
18 Serial number
19 Warning, electricity
20 Warning; laser beam
21 Warning（Risk is middle level）
WEEE
DISPOSAL: Do not dispose this product as

22
unsorted municipal waste. Collection of such
waste separately for special treatment is necessary.
23 Non-ionizing radiation
Content Index
Product summary A
Product safety B
Technology index and environment requirement C
System hardware explanation D
System software illustration E
Installation and debugging F
Optional fittings and subassemblies G
Circuit diagram H
Manufactory’s declaration for Magnetic Resonance
Imaging System---BTI-050 under standard EN 60601-1-2 I

Content
Product Summary ........................................................................................................ 1
A.1 System principle .................................................................................................................. 1

A.2 System usage ....................................................................................................................... 2
A.3 Indication and contraindication ........................................................................................... 2
A.4 Nominating method, model of the system ........................................................................... 3
A.5 Classification of the system ................................................................................................. 3
A.6 Constituents of the system ................................................................................................... 4
A.7 Basic parameter and performance ....................................................................................... 4
A.8 System working conditions and service life ........................................................................ 8
A.9 System operating mode ....................................................................................................... 9
A.10 Patient support ................................................................................................................. 14
A.11 Part of the body or type of tissue applied to or interacted with ....................................... 14
A.12 Operator profile ............................................................................................................... 15
Product Safety ............................................................................................................ 16
B.1 Criteria of safety requirements .......................................................................................... 16
Technology Index and Environmental Requirement ............................................. 37
C.1 Main technology index ...................................................................................................... 37

C.2 Operating environment ...................................................................................................... 45
C.3 Packing, transportation and storage ................................................................................... 46
System hardware explanation ................................................................................... 49
D.1 System hardware overview................................................................................................ 49

D.2 Magnet............................................................................................................................... 50
D.3 Spectrometer...................................................................................................................... 55
D.4 Gradient amplifier and gradient coil.................................................................................. 64
D.5 Transmitting and receiving system.................................................................................... 69
D.6 Magnet automatic constant temperature system ................................................................ 70
D.7 Console .............................................................................................................................. 71
D.8 Patient table and enclosure ................................................................................................ 72
System Software Illustration ..................................................................................... 77
E.1 Brief Introduction .............................................................................................................. 77
I
E.2 MRI System software block diagram ................................................................................ 81
E.3 Software function description ........................................................................................... 83
E.4 Software installation description ....................................................................................... 98
E.5 Software files muster and store path ............................................................................... 109
Installation and Debugging .................................................................................................... 112
F.1 System Layout Illustration .............................................................................................. 112
F.2 System Installation .......................................................................................................... 113
Optional Fittings and Subassemblies ..................................................................... 119
Circuit Diagram ....................................................................................................... 120
Manufacturer’s declaration for Magnetic Resonance Imaging System---BTI-050

under standard EN 60601-1-2 ................................................................................ 124
II
Technical Manual
Part A
Product Summary
◇ System principle ◇ System usage
◇ Indication & contraindication
◇ Nominating method, model of the system
◇ Classification of the System ◇ Constituents of the System
◇ Basic parameter and performance
◇ System working conditions and service life
◇ System operating mode ◇ Patient support
◇ Operator profile
A.1 System principle
Magnetic Resonance Imaging technology utilizes magnetic resonance phenomena to

impose an external magnetic field to make the human body proton magnetic moment array
in order along the direction of the external magnetic field. Besides autorotation, proton
magnetic moment will also make Larmor precession round the external magnetic field.
The relation between movement angular frequency ω and external magnetic field intensity
B0 conforms Larmor relation, i.e. ω=γB0 (γ is Larmor constant). Then transmit
electromagnetic wave through a polarizing coil on the vertical direction of the magnetic
field. When electromagnetic wave frequency and nuclei motion frequency Concorde,
nuclei will absorb electromagnetic wave, general magnetization vector overturns. When
the electromagnetic wave stops, its magnetization vector will restore to the primary state
and transmit radio-frequency signal like pumping frequency. Thus electromagnetic wave
can be received in coil.
In the magnetic field, superpose gradient magnetic field in three directions X, Y, Z; and
Basda Magnetic Resonance Imaging System Page 1 of 128

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make frequency coding and phase coding for the whole magnetic field space. In this way,
the received electromagnetic wave will contain 3D position features. The received
electromagnetic signal will be amplified by electronic devices and changed into digital
signal. Then make computer processing to reconstruct the human body dislocation image
for doctor's analyses and diagnoses.
A.2 System usage
BTI-050 MRI system (hereafter referred to as the system) acquires human body 3D
dissection dislocation images for the information of clinical diagnosis and medical
research in hospitals. It is mainly applied to nervous system, chest and abdomen organs,
skeleton, muscle structure dissection and others.
Warning: This system shall not be serviced or maintained while in use with the
patient.
A.3 Indication and contraindication
System acquires human body 3D dissection dislocation images for the information of
clinical diagnosis and medical research in hospitals. It is mainly applied to nervous system,
chest and abdomen organs, skeleton, muscle structure dissection and others.
Indications of the system: head, chest, kidney, liver, pelvic cavity, ovary, spine, skeleton,
joint and other organic tumour, cyst, infarct, hemorrhage, denaturalization, protrusion, etc.
Main contraindication of the system:
1. Patients with electrocadiac pace-maker;
2. Patients bearing insulin pump；
3. Patients with ferromagnetic metal hemostatic clamps in vivo;
4. Patients bearing metalic, magnetic blood vessel bracket；
5. Patients in emergent illness and not suitable for MRI examination；
6. Patients in early pregnancy within 3 months.

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Patients mentioned above are strictly prohibited to take MRI

examination; otherwise there would be life hazard.
A.4 Nominating method, model of the system
1. Nominate method
BTI-XXX Magnetic Resonance Imaging System
Product name
Model (BTI enterprise code; XXX design serial number, indicated as

030, 035, 050,...showing the main magnetic field strength are 0.30T,
0.35T, 0.50T,…. For example BTI-050 Magnetic Resonance Imaging
System indicates the main magnet magnetic field is 0.50T.
2. Model and name
BTI-050 Magnetic Resonance Imaging System.
A.5 Classification of the system
1. According to the type of protection against electric shock, it is class I equipment.
2. According to the degree of protection against electric shock, it is type B applied part
equipment and the receive coil is treated as type B applied part and detachable part;
3. According to the degree of protection against harmful ingress of water, it is ordinary

equipment (enclosed equipment without protection against ingress of water).
4.According to the manufacturer allowed sterilization type, it is sterilization equipment.
5. According to the degree of safety of application in the presence of a FLAMMABLE

ANAESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUSOXIDE, it
is equipment not suitable for use in the presence of a flammable anesthetics mixture with
air or with oxygen or nitrous oxide.
5. According to the mode of operation, it is continuous operation equipment.
6. According to Rule10 of Annex Ⅸ in 93/42/ECC of the EU Medical Device Directive:

supply energy (nuclear magnetic resonance, Ultrasound device), divided into Class II a.

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A.6 Constituents of the system
The system consists of magnet (0.50T), spectrometer, RF amplifier, gradient amplifier,

industry computer, image monitor, transmit coil, receive coil, gradient coil, diagnose table,
mattress, magnet automatic constant temperature system, laser localizing system,
Two-way voice transmission system, tri-phase insulating transformer and system software
(version: V4.0). There into, magnet, receiving coil, enclosure and diagnose table, mattress,
laser localizing system will be used in the patient environment.
A.7 Basic parameter and performance
1. Magnet System
⑴ Open type, permanent Nd-Fe-B magnet;
⑵ Build-in temperature control system.
⑶ Permanent magnet
2. Coils
⑴ Flat transmit coils;
⑵ Receive coils
Head coil, neck coil，small body coil, large body coil，body coil, knee coil, breast coil,
shoulder coil, ankle coil, wrist coil.
3. Gradient System
Max. Gradient strength ≥10mT/m.
4. Spectrometer
⑴ digital spectrometer;
⑵ RF transmit machine, RF receive machine;
⑶ gradient wave generator.
5. RF amplifier
Output rate ≥5KW;

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6. Computer System
⑴ CPU ≥2800MHz;
⑵ Operating system: Windows ;
⑶ Memory ≥2048MB;
⑷ Harddisk ≥160GB;
⑸ Optical disk RW;
⑹ SVGA display card resolution ≥1680×1050dpi;
⑺ Network card: 100Mbps/1000Mbps;
⑻ image monitor ≥22＂, brightness: 250CD/m2, type: LCD.
7. Image
⑴ To store the images at large capacity hard disk;
⑵ Laser camera or film printer.
8. Scan
⑴ Adjustable range of TR 20ms ～5000ms;
⑵ Adjustable range of TE 10ms ～300ms.
9. Magnet build-in temperature control system
Temperature control precision ±0.1℃.
10. Localization
Laser localization.
11. Patient communication system
Observe window, two-way voice communication system, background music.
12. Technology index
⑴ Permanent magnet magnetic field strength is 0.50T±5%;
⑵ Magnetic field uniformity

Technical Manual
Within φ300mm sphere around the permanent magnet field center, magnetic field
uniformity should be no bigger than 30ppm (Vpp);
⑶ Magnetic field stability should be no bigger than 10ppm/h;
⑷ Dissipation magnetic induction
a. At 2.5m distance to permanent magnet center, no bigger than 0.5mT in horizontal

direction；
b. At 2.5m vertical distance to permanent magnet center, no bigger than 0.5mT in vertical
direction.
⑸ Scanning image technical parameter
a. Two dimensional geometric distortion: proportional geometric distortion should not

more than±2%, variance geometric distortion should not more than2% and maximum
geometric distortion should not more than±5mm.
b. Uniformity
Head coil uniformity≥85%;
Neck coil uniformity≥85%;
Small body coil uniformity≥85%;
Body coil uniformity≥85%;
Large body coil uniformity≥85%;
Breast coil coil uniformity≥85%;
Knee coil uniformity≥85%;
Shoulder coil uniformity≥85%;
Ankle coil uniformity≥85%;
Wrist coil uniformity ≥85%.
c. Spatial resolution modulation factor should not less 0.47, structure is distinguishable;
d. Ghost the ratio of ghost to signal should not more than 5%;
e. Noise-signal ratio

Technical Manual
Head coil ≥ 80;
Neck coil ≥ 60;
Small body coil ≥ 110;
Body coil ≥ 60;
Larger body coil ≥ 90;
Breast coil ≥ 50;
Knee coil ≥ 70;
Shoulder coil ≥ 60;
Ankle coil ≥70;
Wrist coil ≥ 100.
f. Two-dimension scan layer thickness
i. Minimum layer thickness 1mm, typical layer thickness 4mm;
ii. Errors should not more than ±1mm
13. Software function
⑴ Should be able to process system auto-correction；
⑵ Should be able to process magnetic resonance primary signal to construct transverse

plane, sagittal plane, coronal plane or any inclined plane dislocation image；
⑶ Should be able to scan with manifold slices, to display and analyses dislocation image；
⑷ Should be able to backup, restore and delete primary signal data and image data;
⑸ Should be able to expediently compile impulse sequence, such as SE, FSE, GRE, IR,
MRA, DWI, ECG-gated sequence, water imaging sequence, fat-suppression sequence,
FLAIR and others；
⑹ Should be able to make post processing on images. Have function of window width
and level adjustment, characters annotation or cleanup, distance measurement, selection of
interesting region, average pixel value calculation, pixel value standard deviation
calculation and so on.

Technical Manual
14. Measuring function in software system
⑴ Degree of accuracy: 0.5mm;
⑵ Scale: 384mm;
⑶ Units: mm.
A.8 System working conditions and service life
1. Working conditions
⑴ environment temperature 5℃～40℃;
⑵ relative humidity 30% ～70%;
⑶ atmospheric pressure 70.0 kPa ～106.0kPa.
2. Power Supply
⑴ Power supply for scanning room & operating room
～230 V, 50Hz;
⑵ Power supply for gradient amplifier
3N～400 V, 50Hz;
⑶ Rating power 10KVA(not include scanning room air-conditioner & lighting).
3. Scanning room working conditions
⑴ Scanning room temperature 22℃±4℃;
⑵ Equipment room and operation room temperature 18℃-26℃.
4. System mean-time-to double failure
System mean-time-to double failure is longer than 2400h.
5. System expected service life
The expected service life is10 years.
6. Environmental protection requirement
When the system is out of use after the expected service life, the magnet can be

Technical Manual
demagnetized with high temperature. After the demagnetization, handle the magnet and
computer and other electronics parts as per the local laws and regulations. Phantom
solution shall be treated as per chemicals restriction requirements. Otherwise, it may cause
environmental pollution.
A.9 System operating mode
Systemic operating mode is normal operation mode. During normal operation, all the
operating parameters are under the preferred limitation to avoid safety hazard during MRI
scanning. Furthermore, regular monitoring is required during scanning to protect the
patients and MR workers from any hazard.
A.1 Temperature limits
Operating mode Max. core tem. Max. local tissue Rise of core tem.℃
tem.
Normal 39 39 0.5
First level controlled 40 40 1
Second level controlled ＞40 ＞40 ＞1
Background information:
1. The meaning and requirements of various operating mode
⑴ Normal Operating mode
Mode of operation of the MR EQUIPMENT in which none of the outputs have a value
that may cause physiological stress to PATIENTS. And entering this mode, no specific
indication or measure is required to be display.
⑵ First level controlled Operating mode
Mode of operation of the MR EQUIPMENT in which one or more outputs reach a value
that may cause physiological stress to PATIENTS which needs to be controlled by
MEDICAL SUPERVISION. The properties of the MR equipment with respect to
displayed indication before entering this mode and deliberate action when entering this
mode, also, medical supervision shall be provided.
⑶ Second level controlled Operating mode
Mode of operation of the MR EQUIPMENT in which one or more outputs reach a value

Technical Manual
that may produce significant risk for PATIENTS, for which explicit ethical approval is
required (i.e. a human studies protocol approved to local requirements). Specific security
measures shall be provided to prevent unauthorized operation in this mode; operation in
this mode is only permitted under a human studies protocol approved according to local
requirements.
2. System magnetic field time rate of change (dB/dt) and standard absorption rate (SAR)
and static magnetic field.
⑴ Protection against excessive low frequency field variations produced by the gradient
system
Low frequency field variations produced by the gradient system are in this standard the
variations for which the concern is to prevent cardiac or peripheral nerve stimulation (PNS)
(effective stimulus duration >20 ìs).
a. Limits related to prevention of cardiac stimulation
To protect against cardiac stimulation in each operating mode, the gradient output of all
gradient units shall satisfy:
E<2/｛1-exp(-tse,eff/3)｝
where
ts,eff (ms) is the effective stimulus duration;
E (V/m) is the electric field induced by gradient switching
For MR equipment provided with whole body gradient system, this limit may be replaced
by:
Db/dt<20/｛1-exp(-tse,eff/3)｝
where
dB/dt (T/s) is the rate of change of the magnetic field during gradient switching;
ts,eff (ms) is the effective stimulus duration.
b.Limits related to peripheral nerve stimulation (PNS)
Limits of gradient output either shall be based on the results of an experimental study of

Technical Manual
human subjects as described in section ) of this subclause or shall have values as stated in
section ⅱ) of this subclause.
i. Directly determined limits
Limits related to minimising PNS for any given type of gradient system may be based
ondirect determination from a study on human volunteers and are as follows:
– for operation in the normal operating mode, the gradient system shall operate at a
level that does not exceed 80 % of the directly determined mean threshold PNS, and
– for operation in the first level controlled operation mode, the gradient system shall
operate at a level that does not exceed 100 % of the directly determined mean threshold
PNS.
ii. Default values
When no direct determination of limits is obtained, the gradient output limits for the
NORMAL OPERATING MODE (L01) and the FIRST LEVEL CONTROLLED
OPERATING MODE (L12) shall, depending on the label (as defined in 6.8.3 ee) not be
larger than the values stated below:
L12 = 1,0 rb(1 + 0,36/ ts,eff), (ts,eff in ms)
L01 = 0,8 rb(1 + 0,36/ ts,eff), (ts,eff in ms)
where
ts,eff (ms) is the effective stimulus duration and
rb (here in T/s) is the rheobase given in Table 102.

L01 and L12 as well as rb shall either be expressed as the electric field E (V/m)
induced or as the time rate of change of the magnetic field dB/dt (T/s).
A.2 Rheobase values per type of gradient system
Type of gradient system Rb,express as E(V/m) Rb,exprss as dB/dt(T/s)
Whole body gradient

2.2 20
system
Special purpose gradient 2.2 Not applicable

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system
⑵ Limits for SAR

In table A.2, allowed ranges of values of whole body SAR, partial body SAR, head
SAR and local SAR are given for normal operating mode and first level controlled operating
mode. For the second level controlled operating mode, no limits are given. These limits are
considered the responsibility of the local investigational review board that has authorized its
use.
The mass used to determine the WHOLE BODY SAR is given by the PATIENT mass.
The mass to determine the PARTIAL BODY SAR is called exposed PATIENT mass. It is
given by the PATIENT mass within the effective volume of the RF transmit coil. The
effective volume of the RF transmit coil shall be that volume in which no more than 95 % of
the total absorbed RF power is deposited inside a homogeneous material which fills the
volume normally accessible by the PATIENT. The mass to determine the HEAD SAR shall
be the mass of the head approximated by a suitable model. The mass to determine the
LOCAL SAR shall be 10 grams.
A.3 SAR limits
Averaging
6min
time
Whole Partial Head

Local SAR
body SAR body SAR SAR
Exposed
Body region→ Whole body Head Head Trunk Extremities
body part
Operating （ W/kg （ W/kg （ W/kg （ W/kg （W （ W/kg

mode↓ ）））） /kg））
normal 2 2~10a 3.2 10b 10 20
First level
4 4~10a 3.2 10b 10 20
controlled
Second level ＞
＞4 ＞3.2 >10b >10 >20
controlled (4~10a)

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Short term SAR The SAR limits over any 10 s period shall not exceed three times the stated values
a The limit scales dynamically with the ratio "exposed PATIENT mass / PATIENT mass":
NORMAL OPERATING MODE :
PARTIAL BODY SAR = 10 W/kg – (8 W/kg * exposed PATIENT mass / PATIENT mass)
FIRST LEVEL CONTROLLED OPERATING MODE :
PARTIAL BODY SAR = 10 W/kg – (6 W/kg * exposed PATIENT mass / PATIENT mass)
b In cases where the orbit is in the field of a small LOCAL RF TRANSMIT COIL, care should be taken to
ensure that the temperature rise is limited to 1 °C.
For WHOLE-BODY SAR, the values in table 105 are valid at environmental
temperatures below 24 °C. At higher temperatures, these values shall be reduced depending
on actual environmental temperature and humidity. The reduction of SAR limits for
environmental temperature starts at the derating temperature. The derating temperature is
25 °C for relative humidity <60 %. For each 10 % increase of the relative humidity in excess
of 60 %, the derating temperature is reduced by 0,25 °C (e.g. 24 °C at 100 % relative
humidity).
For each degree of environmental temperature that exceeds the SAR-derating

temperature, the WHOLE-BODY SAR limit shall be reduced by 0,25 W/kg until the SAR is
2 W/kg or 0 W/kg for FIRST CONTROLLED OPERATING MODE or for NORMAL
OPERATING MODE, respectively.
⑶ Protection against exposure to static magnetic fields
The static magnetic field of the MR EQUIPMENT is the operating magnetic field
strength.
For the static magnetic field, the following operating mode limits apply:
a. The normal operating mode comprises values of the static magnetic field equal or
lower than 3 T.
b. The first level controlled operating mode comprises values of the static magnetic
field higher than3 T and equal or lower than 4 T.
c. The second level controlled operating mode comprises values of the static magnetic

Technical Manual
field higher than 4 T in the isocentre.
Physiological effects, such as vertigo and nausea, due to the movement in the static
magnetic field for both the patient and the MR worker shall be minimized. so that the
speed of movement shall be limited ,the speed of motion for the MR worker shall be no
more than15m/s in the controlled access area and the relevant worker should be imparted
the limit by training.
A.10 Patient support
1. Age: not relevant;
2. Weight:≤200Kg;
3. Heath: Anyone except person who is contraindicated by the system;
5. Nationality: Multiple
6. Patient state
The following patients must be worshipped on site by medical care personnel during
MRI examination:
Severe patients (like potential cardiac arrest) at vitality risk at any time；
Patients can not have a reliable communication due to their visual, hearing and
linguistic objection and other particular cases;
Patients can not keep a reliable communication due to their insensibility, over
equanimity or puzzle headedness;
Patients with the possibilities of outburst disease, incarceration phobia, cardiac

decompensation or perspiration dysfunction and other cases.
Patients are not able to communicate with the clinician via verbal system due to some
specific causes;
First aid equipment should be prepared at MRI examination site but out of 0.5mT line.
A.11 Part of the body or type of tissue applied to or interacted with
1. Measurement site: helmet, neck, body, knee, spine, shoulder, breast, wrist, ankle.

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2. Condition: in the centre of magnetic field.
A.12 Operator profile
1. Qualification :
Minimum
Medical imaging specialty;
Having medical practicing license and the work license of large-scale medical apparatus
(MRI technologist or physician).
No maximum
2. Training:
Training provides knowledge and skills required for safe and effective use of equipment
by the manufacturer or qualification by coaching operator.

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Part B Product Safety
This chapter means to describe medical MRI system theoretical principle for better
understanding on product safety requirements. The chapter includes:
◇ criteria of safety requirements
B.1 Criteria of safety requirements
◇ MR influence on human health
◇ Influence of heart pacemaker and metal implant in vivo
◇ Gradient field noise
◇ Human body bad psychological reaction
◇ Influence on pregnant woman
◇ Ferromagnetic radiator
◇ Radio-frequency interference (RFI)
◇ Radio frequency hazard
◇ Controlled approaching area
B.1-1 MR influence on human health
There are three factors influencing human health from MRI technology:
1. Main magnetic field: strong with unaltered intensity magnetic field；
2. Gradient magnetic field: comparatively weak but quick changing magnetic field；
3. Radio frequency electromagnetic field.
Main magnetic field: Influence on human health from unaltered intensity high magnetic

Technical Manual
field caught people's attention long time ago. When human body enters high magnetic
field (above 0.3T), cardiogram will change, which will disappear till removing the external
magnetic field.
Research shows when putting an animal under 3.7T magnetic field, high magnetic field
does not damage genetic factors. As per enunciable material, magnetic field intensity
under 20T will not change enzyme activity of biological tissue.
Gradient magnetic field appears on chance during scanning. As a conductor, human body
tissue will generate induced electromotive force when the magnaflux changes, this will
lead to partial induced current and some pathologic reactions such as pseudophotoesthesia,
skin allergy, jerk, even ventricular fibrillation. As per calculation, when magnetic field rate
of change is 1T/s, induced current within 1 square centimeter is less than 1 microampere.
Comparing with nervous activity electric potential (300 mA/cm2), tissue internal induced
current is quite small during MR examination. But because of current density should be
less than 3mA/cm2, otherwise it might cause ventricular fibrillation. This potential threat
should be watched carefully. At routine MR examination, rate of change in gradient
magnetic field must be less than 20 T/s, then the insurable current density should be lower
than 3mA/cm2. Vitiating magnetic field will also cause "magnetic fluorescent"
hallucination, when eyes are exposed to 100 Gauss. 20-40Hz alternating magnetic field,
they will see flare or color ring. This ocular chaos may be caused by magnetic field effect
on retinas photoreceptors. This kind of visual physiological effect will disappear after
removing the alternating magnetic field.
During scanning, gradient coil changes magnetic field quickly, which may
cause stimulation on peripheral nerves or tingling on some patients. To
reduce possibility of peripheral nerve irritation, please ensure the patient will
not hold or touch their hands, nor cross their feet to avoid forming a
conductor return circuit.
Influence of radio frequency electric wave irradiation on human body is that tissue will
have temperature effect after absorbing RF electric wave. When examine some human
body part with nuclear magnetic resonance spectrum analyzer, maximum energy
absorption rate of tissues can be around 4W/Kg. If the examination time is 10 minutes,

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theoretically body temperature will increase 0.7℃. Poor blood supply vessels in some
tissue will be sensitive to heat changes such as eyeball, epitaxy, and testis. But in fact,
tissues are always radiating heat peripheral and furthermore radio pulse does not like
microwave or infrared ray, Its "heating" effect is quite faint thus cause no hazard to human
health.
MR workers can be exposed to the electromagnetic fields (EMF) emitted by the MR

equipment in the controlled area. Sufficient information relating to the risks from these
exposures to enable safe working procedures for the MR worker should be provided,
which includes: specification of areas to which access by the MR worker is restricted, if
any; the actual levels of the exposure in all areas accessible to the MR worker, expressed
in proper units for the static magnetic field, the gradient output and the RF transmit field
generated by the MR equipment; instructions that the MR worker shall be informed and
trained sufficiently so that they can perform all their tasks safely in a way that minimizes
their exposure to EMF emitted by the MR equipment; a statement that there is a possibility
that mild peripheral nerve stimulation (PNS) may be induced in the patient and MR
worker when exposed to the gradients in the first level controlled operating mode.
However, the system is in the normarl mode and the risk from the exposure is tiny.
Some ways for the MR worker to mitigate these risk factors are following:
⑴ keeping sufficient distance away from the transmit RF coil or by reducing time of
exposure during scanning;
⑵ keeping sufficient distance away from the gradient coils during scanning;
⑶ staying away from the magnet (not just during scanning but all the time) and by
avoiding rapid movements of the head while in the static magnetic field.
Research on integrative biological effect of MRI system, it means under the simultaneous
effect of main magnetic field, alternating magnetic field, RF electromagnetic field, shows
MRI system examination will not cause biological damages such as damages on genetic
factors and others.
In general, abundant animal experiments and clinical application prove harm on human
health from MRI system's main magnetic field, alternating magnetic field and RF electric
wave is much less than that caused by X-ray CT (Harm of ionizing radiation from X-ray

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CT on human body is well-known).
The limits for MR workers are not be applicable when the MR workers is pregnant. it might
be required in some countries that the ‘member of the public’ limit be applied to the foetus,
which implied that the pregnant MR worker is not allowed to be present in the examination
room during scanning.
Magnetic field used in magnetic resonance will cause subtle gene and
numerator changes. Please weigh the conflict of interest by using
MRI system and the other alternative procedures before control the
harm on patient from scanning.
Be cautious to restrict the exposing time for patients as per local

regulations on exposition in magnetic field.
B.1-2 Influence of heart pacemaker and metal implant in vivo
Patients bearing heart pacemaker, must stand far away from MR system. The modern heart
pacemaker is weighted around 50-70g and packed in a stainless steel box. When heart rate
is lower than threshold value, detection circuit will give order to the pacemaker and
impose the electric impulse (usually it will be 5V, 10mA and 1ms) directly onto cardiac
muscle. Due to various heart pacemakers and their different performance, it is hard to
make a conclusion on its failure under effect of MR system. The most common failure
reasons are: electromagnet static field closes the electric relay, which lead to heart rate
detecting circuit out of service. Then pacemaker will impose electric impulse onto heart
continuously despite of heart rate and necessity of pacemaker power supply. 10 Gauss
(within 5 meters from 0.5 T magnet) magnetic field intensity will create this failure. In fact,
this method is used clinically to test pacemaker: Doctors put some magnet with certain
magnetic field intensity against patients with pacemaker on the chest and record the
cardiogram to test the pacemaker functional state. So failure caused by a fixed magnetic
field is not much risky. Instead there will be more risk from RF radio wave and alternating
magnetic field because detecting circuit can not identify their impulse from electro-cardiac
impulse. As a result, pacemaker may not work when it is needed. Besides this, powerful

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magnetic field may bring embedded pacemaker displace at times. Therefore, patients
bearing pacemaker can not have MR examination and should stay far away from MR
scanning room.
Ferromagnetic implanted in body will damage MR image quality; meanwhile, high

magnetic field will cause displacement of some metal clips implanted during operation.
Thus the tissue damage or hemorrhage caused by vascular clamp fall off might threaten
patients' life. In consideration of MRI technology is clinically used more and more
frequently, it is required to use non ferromagnetic clamps instead of stainless steel clamps.
If the implant device is labelled as MR safe or MR conditional, the operator should read
the further explanation described in the accompanying documents of the implant
manufacturer .
B.1-3 Gradient field noise
For the safety of patients and the persons concerned, use hearing
protection device when necessary.
Gradient coil will cause very strong Lorentz force, which leads to thermal agitation of coil
bearer during gradient field transition and some special noise during scanning. Noise of
MRI equipment mainly is gradient field noise. Very high noise does not only influence
communication between doctors and patients, but also make some psychological or
physiologic hurt on patients to some degree. Psychological hurt refers to aggravated fears,
which might be the evocation reason of epilepsy and mental incarceration. Therefore, MRI
gradient field noise is a security problem that should not be neglected.
During scanning, gradient coil in the magnetic field might generate noise at maximal A
weighted effective quantity sound pressure (LAeq.lh) 95dB (A), the operator should
control the sound level as per local laws and regulations.
For the safety, patients, MR workers and the persons concerned shall ware adequate
hearing protection to reach compliance with the rules for protection to noise, especially in
the controlled access area during scanning. The hearing protection fitting can be foam
material earplug.

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The operator should pay special attention to place hearing protection fitting rationally and
trained personnel are preferred. Especially, should handle carefully the newborn infant and
premature baby who can not use standard earmuffs or can not use any protection.
The operator should pay attention and evaluate the acceptable sound pressure level on
pregnant women and fetus, newborn infants, infants and old people because of their
continuous ascending anxiety.
The operator should pay attention that protection of patients under anesthesia state is likely
to be lower than normal state. Thus their hearing protection should not be neglected even
at moderate sound level.
Employees working around the system regularly are possible to suffer from the noise,
please take it as per local law and regulations.
A weighted effective quantity sound pressure level (LAeq.lh) is measured by sound level
meter under the following settings:
Sensor: Actual value
Time weight: Quick or slow
Frequency weight: A weighted
Measurement period: ≥ 20s
B.1-4 Human body bad psychological reaction
During MRI examination, due to narrow and small magnet space in which the patient stays,
and gradient field noisy interfere, some patients show their anxiety, panic or feel down in
spirits or other reactions, even mental incarceration in some severe case. The following
methods can reduce these adverse reactions to a greater or less extent:
1. Allow companion of families or friends in the scanning room;
2. Provide MRI compatible earphone and play music；
3. Keep on talking with patients or in other communication.
B.1-5 Influence on pregnant woman

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Safety of magnetic resonance scanning on fetus and children has not

been proved yet. Before control the harm of scanning on patients, please
weight the conflict of interest between magnetic resonance and the other
alternative procedures and let the doctor decide if the pregnant woman
or children patients should take scanning or not.
The safety of MRI examination on pregnant women actually concerns whether the
development of fetus is influenced by magnetic field (including static magnetic field and
gradient field) as well as radio-frequency field, that is whether MRI is teratogenic or not.
But then, up to now, research on teratogenic action is not thorough enough. It is still a
disputable topic that safety of MRI on pregnant women. Wherefore, America FDA (Food
and Drug Administration) has not made any explicit regulation on the safety of MRI
examination on pregnant women (fetus) and infants. Britain NRPB (National Radiation
Protection Board) only suggests that it should be cautious to use MRI for the first three
months pregnancy. The foetus is especially sensitive to potential thermal events during the
first trimester, The responsible organization should be advised to avoid scanning patients in
the first trimester or with unknown pregnancy status.
Mainly due to the following two aspects, it should be cautious to MRI examination on
pregnant women: First, in the abstract analyses, MRI electromagnetic field can generate
biological effects on up growth fetus through multifold ways; Secondly, cellula during
differentiation is apt to be damaged due to many physiologic factors interference.
Scanning of pregnant PATIENTS with the WHOLE BODY RF TRANSMIT COIL should be limited to
the NORMAL OPERATING MODE with respect to the SAR level.
B.1-6 Ferromagnetic radiator
Magnetic field gravitation in the protected zone can change ferromagnetic

(that is objects containing ferrum, nickel, cobalt and other alloys) into
projectiles. At the same time, it will make contraindicated biomedical
implant out of service; So that ferromagnetic and incompatible biomedicine
implants are not allowed to enter protected zone.
For the moment, clinical MRI system static magnetic field strength is between 0.2-1.5T,

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the potential hazard of this high magnetic field is projecting effect. Projecting effect refers
that under high magnetic field effect, ferromagnetic object throws at magnet from other
place at a certain speed.
Projectiles around MRI magnet mostly are surgical apparatus, oxygen bomb, medical
devices and especially those monitoring devices, stretcher, wheelchair as well as those
metal items carried by the subject. Knife, metal zipper, metal button, fountain pen ( ball
pen), keys, coins, jewelries, hair pin, watch, lighter, mobile telephone, pager audiphones
and other ferromagnetic objects and metal items easily carried or worn by the patient.
To prevent ferromagnetic projectiles threat to the equipment and human body, MRI room
should set up a full range of security countermeasures. Put up well marked caution mark at
the entrance of magnet room and keep close supervision on personnel entering the room.
B.1-7 Radio-frequency interference
Normal operation of biomedical devices may interfere the protected area

and cause personnel injury.
Other hospital devices can be influenced when approaching the magnetic

field and the MRI image quality is likely to be influenced by these devices.
Within the controlled area, MRI system does not meet the current radio requirement in
general. This is used to protect telecommunication, allowed limitation of radio frequency
emission is from 30dBμV/M to 50dBμV/M as per the prescription in international
standard (e.g.CISPR11). The expected anti-interference requirement for conventional
equipments is 1N/M or 3V/M. For special equipments, such as vital support and some
patient monitoring devices, the anti-interference requirement is from 10V/M or 100V/M.
In fact, around the MRI system and its controlled approaching area, radio-frequency field
intensity is apt to exceed this limitation, even exceed 100V/M. It is obvious that those
peripheral equipments used in the controlled approaching area will be interfered by any
possibility.
The MRI system radio-frequency signal is likely to influence those devices in neighboring
facilities or patients, operating personnel and someone else, as well as their electronic

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equipments within MRI system area or its neighboring areas. The system is likely to cause
radio-frequency interference on the other medical or non-medical devices and
telecommunication.
If interference is detected, it can be confirmed by turn on and off the system. The
following methods can be used to rectify:
Re-arrange the direction or place of the affected devices
Enlarge the distance between the system and the affected device
Do not use devices designed to transmit radio-frequency signal, mobile telephone,

transceiver, radio-telecontrol products. They may make the system fail to reach the
performance as its manual states. And please shut down these devices when approaching
to the system.
The operator should consider avoid the following factors which may cause partial radio
frequency superheat:
1. Conduct (metal) object or implant exists within the sensitive areas of radio frequency
emission coil;
2.Usage of per-skin medicine likely to induce subsurface burnt；
3. Skin contact is likely to form a partial body galvanic circle, such as: inside thigh - thigh,
leg - leg, hand - hand, hand - body, ankle - ankle contact;
4.Existence of moist clothing；
5. Body or limbs stay on radio frequency emission coil surface；
6. Patient contact with radio frequency receiving coil cable or its peripheral wiring;
7. Circuit between radio frequency receiving coil cable and ECG led;
8. Using of incompatible ECG electrode and led; The operator should use electrode within
service life；
9. Patients taking depressant or losing their consciousness, or partial anesthesia (such as

hand or leg paralysis) or being not able to remind the operator the overheating or tissue
damage;

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10. Cables staying in radio frequency emission coil but not connecting with coil.
B.1-8 Radio frequency hazard
Radio frequency will happen during scanning, which may lead to

the following hazard:
1. Tissue heating
If radio transmitting is speedier than radio scattering, radio frequency will heat tissues.
The heating degree of patients’ tissue depends on patient weight, impulse sequence type,
timing, slice quantity, and some imaging option, for example saturation.
Tissue temperature raise caused by radio frequency depend on homoiothermism system or

surrounding environment and other factors. Homoiothermism system is an ability of
maintaining a normal thermal capacity level. Body temperature increase will reduce the
homoiothermism system function and cause hazard, but the homoiothermism function
decline may be caused by some reason exited previously. Such as heart damage,
hypertension, diabetes, senility, fatness, fever or perspiration dysfunction, that will cause
circulatory function descending. If the patients are under these cases, they should be
inspected at any moment.
2. Magnetic hole heating
Radio frequency leads to magnetic hole temperature rise and thermocompression;

Medication may weaken the patients' adaptability to external temperature increase;
Indoor temperature should be set under 22 centigrade. Always keep on the fan to ensure
ventilation in magnetic hole.
3. Contact point heating
Radio frequency may create partial heating on contact points between patients and
magnetic hole or patients and radio frequency coil, which cause comfortlessness and
sensation of burning heat.
Closely hold fists, hand and body contact, or personal touch in a small compass may form
closed circuit. To prevent patients from be burnt by closed circuit, put some non-conductor

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pad between the contact sites.
Put foam material at any contacting point between patients or their body parts and
magnetic hole contacting an open magnetic field.
Put a sheet or pillowcase between coil surface and patient skin to avoid getting burnt.
4. Metal object heating
Cosmetics containing metal materials can heat and irritate skin. Guide the patients to clean
out makeup to prevent eye hazard before examination.
Tattoo and permanent eye line implant contain metallic dyes which can cause heating and
irritate skin.
Jewelries with 14K gold can heat can lead to get burnt. Radio frequency can make metal
heat to lead to get burnt.
5. Cable/conductor heating
Radio frequency can cause incompatible surface coil/gating cable to heat. Damaged
surface coil and gating cable, surface coil not connected with power well, cable connected
incorrectly all will lead to get burnt.
B.1-9 Controlled access area
Must setup warning sign of protected area at the entrance of the

scanning room
In the scanning room, there must no iron oxygen bomb, iron

wheelchair, iron gurney, iron IV (intravenous transfusion) steeve,
iron ventilator and others. Make any people approaching to MRI
system know that only nonferrous objects can be allowed to enter
the scanning room，at the same time set up regulations describing
carrying medical devices and others into the scanning room.
The operator and other personnel are duly to obey the local legal requirements on entering
controlled approaching area.

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The controlled approaching area, within 0.5mT fringe magnetic field around the MRI
system, is given in the magnetic field profile. The user is obligated to mark clearly on the
scanning room floor the range of controlled approaching area.
The diagram of the controlled access area
Description
1. The above size of scan room is min. Specification 5m×6m×3.2m;
2.“+”is Isocentre.
Personnel entering 0.5mT fringe magnetic field controlled approach area are under
potential hazard, which includes suction from objects containing iron or other magnetic
materials, moment of torsion imposed on these metallic materials, as well as their medical
implant may be out of service which will result in potential hazard.
Within controlled approach area, should use non ferromagnetic devices and tools. If

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engineers need to carry small ferromagnetic tools into this area, please fix them first.
Peripheral equipments are not preferred to be used in controlled approach area, including
patient monitoring devices, life support fittings and emergency nursing devices, which
may suffer interference from radio-frequency field or fringe magnetic field of the MRI
system or they may interfere the normal work of MRI system.
The following objects are likely to interfere MRI system imaging, even compose physical
hazard on the users. Please check whether the following objects are with you: heart
pacemaker, embedded nerve stimulator, aneurysm clips, aorta clips, artificial heart valves,
insulin pump, audiphones, joint prosthesis, metal stick, metal sheet, metal pin, screws,
clamps, bone or joint nails, metal wire suture, false teeth, flitter in eyes and cochlea
implant and others. When entering the scanning room, do not carry any following metal or
magnetic-sensing objects: removable dental filling substance, audiphones, bijouterie,
watch, purse or wallet, fountain pen or pencil, key, coin, metal zipper or button, magnetic
card, credit card, bankcard, hair pin, metal bra hook, safety pin and others.
Magnetic field is able to move or dislocate ferruginous implant (such as:

aneurysm clips, surgical clamps and cochlea implant and others) and
artificial limb to cause grievous injury. Do take enquiry measures to prevent
implant and prosthesis hazard. Patients carrying implant can not take MRI
scanning and the prosthesis must be taken away before scanning to prevent
injury.
Metal implant may generate evocation electric current and be heated so that
patients bearing implant are not allowed to take scanning.
B.2 Product safety specific requirements
1. It is not suitable for the following people to operate and use the MRI system:
⑴ People implanted with active life support system powered by electricity,
magnetism or mechanism, such as people with heart pacemaker;
⑵ People implanted with metal items, whose life may be endangered in high

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intensity field due to metal clip felling out or metal item moving away;
⑶ Women during pregnancy are suggested to avoid operating and using the system.
2. MRI inspection is operated in high intensity field, any ferromagnetic materials are not
allowed to be brought into the scanning room, including watch, glasses, removable denture,
artificial eye, artificial limb, metallic article (such as chest pin, key, necklace, bracelet,
hair pin and so on), knife, credit card, communication tools (such as mobile telephone,
Beep-Pager, interphone and so on), different metallic electric tool (such as iron,
screwdriver, spanner, metal tongs), trolley oxygen bomb, planchet, tweezers, surgical
instruments, metal bottle bracket, syringe needle, first aid instruments and so on;
3. It is a must to discriminate the patient before MRI inspection; they are not allowed to
take MRI inspection if they are in the following case:
⑴ Patient implanted with electric, magnetic or mechanic vitro active life support
system. Magnetic field or electromagnetic field caused by MRI system may cause strong
gravitation or moment, or interfere the normal work of these systems and lead to injury of
danger to the patient's life.
⑵ Patients with metallic hemostatic clamp or metal extraneous material in vivo after
operation (unless these metal hemostatic clamp or metal extraneous material are not
ferromagnetism as per the clinician). Magnetic field or electromagnetic field caused by
MRI system may cause strong gravitation or moment to cause these metal hemostatic
clamp fall off or cause metal extraneous material move away so as to lead to injury or
danger to the patient's life.
⑶ Patients at death's door and are in need of emergency treatment but not caused by
MRI system and its physical environment should be checked quickly to save the time on
medical treatment to save the life.
⑷ Patients are in the cases of professional activities, clinical history, existing medical
treatment state and others will be on the line due to exposure in high intensity field caused
by MRI system.
4. When do laser positioning, laser positioning device can only used in the described way,
inform the patients of the damage that laser beam to the eyes. Close their eyes during the
positioning process and promise the patients’ eyes don’t look the laser beam directly.
5. The user must build up a full range of patient supervisory program to ensure the safety
of patients during MRI examination. Routine monitoring on patients should be followed

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during MRI examination, which is to keep in bidirectional audio visual connection with
patients via scanning room observation window, voice transmission system.
6. The following patients must be worshipped on site by medical care personnel during
MRI examination:
⑴ Severe patients (like potential cardiac arrest) at vitality risk at any time；
⑵ Patients can not have a reliable communication due to their visual, hearing and
linguistic objection and other particular cases;
⑶ Patients can not keep a reliable communication due to their insensibility, over
equanimity or puzzle headedness;
⑷ Patients with the possibilities of outburst disease, incarceration phobia, cardiac
decompensation or perspiration dysfunction and other cases.
⑸ Patients are not able to communicate with the clinician via verbal system due to
some specific causes;
⑹ First aid equipment should be prepared at MRI examination site but out of 0.5mT
line.
7. In consideration of magnetic field and other risks, it is the responsibility of the user to
set up a full range of emergency medical treatment measures against patients and, to
ensure that the patient can be transferred safely for treatment in case the patient fall
sick or be injured by other reasons. When in emergency, the user must stop scanning and
get the patient out from magnetic field and the scanning room for treatment.
8. During MRI examination, the gradient field driver quickly changes the direction and
intensity of the magnetic field so as to cause the gradient line to generate mechanical
vibration and some noise. To avoid hearing injury, the patient and MR worker ought to
wear hearing protection device during MRI examination.
9. When applying any physiologic monitoring device and sensing device on the patient,
the user must give instructions on how to use it and it is forbidden for the patient to make
bold with any physiologic monitoring device and sensing device.
10. It is forbidden to make bold with those auxiliaries such as physiologic monitoring,
gating facilities, radio frequency coils, and others, which are not authorized neither tested
in particular to be used together with MRI system. Even auxiliary devices marked with
compatible with MRI system, it may be risky if they are not used under the instructions,

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esp. the explanation of the current-carrying electrode riding position. Our company shall
not assure any responsibility for the burnt or other bad aftermath caused by malpractice of
the manual.
11. It is suggested to prepare fire extinction equipment and device around the scanning
room, and it is better to contact with local related department to discuss the fireproofing
matters and formulate emergency measures. Check and remove any fire hazard. Once it is
on fire, evacuate the patients and cut off the general supply for MRI system room, and take
urgent fire extinction work immediately. When arranging and using the fire extinction
equipment and device, magnetic field impact must be taken into consideration in case they
are adhered by magnet.
12. In consideration of contamination to the MRI system assemblies and the scanning
room by some patient with contagion, traumata and other interior different diseases.
Wherefore, after examining the patient with contagion, traumata, the bedclothes and
correlating assemblies (such as receive coil, diagnoses bed, magnet enclosure and
others)of the MRI system must be wiped for disinfection with 75％alcohol, and the room
can be disinfected by uviol lamp to avoid cross infection.
13. The user must put up some permanent warning, prohibition signs easy understanding
in the scanning room; and appoint some professional staff to explain or advice those
people with dysopia or the other disabled who can not see clearly or understand well.
14. The power supply of each part must be cut off when this part's cover cap or door is
opened. At the same time, please pay attention to those parts (e.g. radio frequency
amplifier) needing some time to discharge completely after power offer. It is not forbidden
to open the cover cap, panel or door.
15. The distribution of system 0.5mT line and fringe magnetic field under installation
condition as show in the graph. There is a striking 0.5mT line logo in the ground of
scanning room, carry out full control to unauthorized persons that access to this region.
For the purpose of safety, eye-catching signs to forbidden active implant and metal
implant must be put up on the outside wall of the scanning room. At the gate of the
scanning room, should put up" High Magnetic Field" warning sign, magnet
radio-frequency field and other items containing ferromagnetic materials out-of-bounds
warning sign; A strict control over any people, facility or article entering the scanning
room. And within the controlled approaching area, even those recommended serviceable

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monitoring devices, life support devices, emergency nursing facilities nor therapeutics
electronic devices are not allowed.
16. For phantom used during quality control, some liquid is sealed inside, please do not
have body contact with the liquid of the phantom. Please store the phantom in a safe room
temperature and do not fell it off nor refit it. The user must ensure that the phantom liquid
will not be expelled into waste water and treat the liquid as per the correlating regulations
of the country.
17. Image artifact may influence the diagnoses, which may be caused by technological or
physiological factors. The operator should choose the most appropriate parameters to
reduce image artifact.
18. The instructions for use shall recommend that training is needed for the MR
WORKER to operate the MR EQUIPMENT safely and effectively. This training shall
include emergency procedures, including those for the issued describes in this subclause
under:
⑴ Emergency medical procedures;
⑵ Controlled access area;
⑶ Fire precautions.

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Spacial distribution of field for XY plane
Spacial distribution of field for ZX plane

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Interaction between MRI equipment and peripheral equipments

磁体与外部的相互影响
Horizontal distribution of RF field

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Note: When the RF power is 5KW, the center field (corresponding to the icon position 6.85) is 40μT.
Vertical distribution of RF field
Maximum main magnetic field spatial gradient location map

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The position with color is the maximum of B0 gradient and average value is 38
T/m(Look the ruler display and read the corresponding value according to the color
change)
The specific location is near two cirque 546mm in radius with (0,0,215) and (0,0,-215)
as the center in the XY plane as show above around the color position.
The position with color is the maximum gradient product of the magnetic field B0 and
spatial gradient of B0 and average value is 54 T2/m(Look the ruler display and read the
corresponding value according to the color change). The specific location is near two
cirque 546mm in radius with (0,0,215) and (0,0,-215) as the center in the XY plane as
show above around the color position.

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Part C Technology Index and Environmental

Requirement
C.1 Main technology index
1. Magnet System
⑴ Open type, permanent Nd-Fe-B magnet, build-in temperature control system;
⑵ Permanent magnet magnetic field strength is 0.50T±5%;
⑶ Magnetic field uniformity
⑷ Magnetic field stability should be no bigger than 10ppm/h;
⑸ Dissipation magnetic induction
At 2.5m distance to permanent magnet center, no bigger than 0.5mT in horizontal

direction；
At 2.5m vertical distance to permanent magnet center, no bigger than 0.5mT in vertical
direction;
⑹ Aperture size: 350mm;
⑺ Bed widths no less than 800mm;
⑻ Weight is 27000Kg;
⑼ A typical magnetic field spatial distribution of surrounding field in plots, as shown in

Fig.C.1, C.2 .

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C.1 Spacial distribution of field for XY plane
C.2 Spacial distribution of field for ZX plane
(10) The position where the spatial gradient of the main magnetic field is a maximum, as
shown in Fig.C.3, the value is 38T/m.the location is near two cirque 546mm in radius with
(0,0,215) and (0,0,-215) as the center.

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C.3 ZY The position where the spatial gradient of the main magnetic field is a maximum,
⑾ The position where the product of the magnitude of the magnetic field B0 and the
spatial gradient of B0 is a maximum, as shown in Fig.C.4，and the value of B0 and the

spatial gradient of B0 at that location, the value is 30T2/m. The location is near two cirque
546mm in radius with (0,0,215) and (0,0,-215) as the center.
C.4 ZYThe position where the product of the magnitude of the magnetic field B0 and the
spatial gradient of B0 is a maximum
⑿ The dimension of magnet(length×width×height): 2160mm ×1965mm ×

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1923mm.
⒀ The gap of magnet is 440mm.

2. Coils
⑴ Automatic identify, automatic tune;
⑵ Type
Flat transmit coils;
Receive coils:
head coil, neck coil，small body coil, large body coil，body coil, knee coil, breast coil,
shoulder coil, ankle coil, wrist coil.
⑶ Quadraqure, or phase array.
3. Gradient System
⑴ Max. Gradient strength ≥10mT/m;
⑵ Non-linearity ＜3%(φ300mm sphere);
⑶ Rise time ≤0.3ms.
⑷ The maximum gradient slew rate: 60mT/m/ms;
⑸ Max. peak voltage 150Vdc;
⑹ Max. peak current 150A;
⑺ The whole body gradient system;
⑻ Spatial distribution of the maximum magnetic field vector for gradient system stray
field along the patient axis and on a cylinder with a diameter of 0.2m,0.3m according to
requirement of IEC60601-2-33 is displayed the following plot C.5 and C.6.

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C.5 Gradient out along the patient axis
C.6 Gradient output on a cylinder with a diameter of 0.2m, 0.3m
4. Spectrometer
⑴ Digital spectrometer;
⑵ RF transmit machine, RF receive machine;
⑶ Gradient wave generator.
5. RF amplifier
⑴ Frequency 5MHz - 130MHz, adjustable;
⑵ Max. Output rate ≥5KW.

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⑶ Gate and overload protection, Cooling method: air cooling.
⑷ Nominal frequency range: 9.4 MHz;
⑸ Types of RF transmit coils, orthogonal coil;
⑹ Max. RF transmit field band width is 100kHz；
⑺ Type: volume RF transmit coil
⑻ The maximum specified B1+RMS for volume RF transmit coil is 40μT, and the
spatial distribution of the maximum RF transmit field at the positions accessible to and
relevant for the MR worker is shown below C.7.
C.7 the spatial distribution of the maximum RF transmit field
6. Computer System
⑴ CPU ≥2800MHz;
⑵ operating system: Windows;
⑶ memory ≥2048MB;
⑷ harddisk ≥160GB;
⑸ optical disk RW;
⑹ SVGA display card resolution ≥1680×1050dpi;
⑺ network card: 100Mbps/1000Mbps;

Technical Manual
⑻ image monitor ≥22＂, brightness: 250CD/m2, type: LCD.
7. Image
⑴ To store the images at large capacity hard disk;
⑵ Laser camera or film printer.
8. Scan
The shortest scan repetition time(TR) is no more than 7ms
The shortest scan echo time(TE) is no more than 3.5ms
9. Magnet build-in temperature control system
Temperature control precision ±0.1℃.
10. Air condition system
Scanning room 22±4℃.
11. Patient support
Laser localization, The max. moving distance of examine bed is 2380mm and Max. load is
200kg.
12. Patient space
Observe window, two-way voice communication system and background music.
13. Localization
Laser localization.
14. Patient communication system
Observe window, two-way voice communication system, background music.
15. Image
⑴ Two dimensional geometric distortion: proportional geometric distortion should not

more than±2%, variance geometric distortion should not more than2% and maximum
geometric distortion should not more than±5mm.
⑵ Uniformity

Technical Manual
Head coil uniformity≥85%;
Neck coil uniformity≥85%;
Small body coil uniformity≥85%;
Body coil uniformity≥85%;
Large body coil uniformity≥85%;
Breast coil uniformity≥85%;
Knee coil uniformity≥85%;
Shoulder coil uniformity≥85%;
Ankle coil uniformity≥85%;
Wrist coil uniformity≥85%.
⑶ Spatial resolution modulation factor should not less 0.47, structure is distinguishable.
⑷ Ghost the ratio of ghost to signal should not more than 5%.
⑸. Noise-signal ratio
Head coil ≥80;
Neck coil ≥60;
Small body coil ≥110;
Body coil ≥60;
Larger body coil ≥90;
Breast coil ≥50;
Knee coil ≥70;
Shoulder coil ≥60;
Ankle coil ≥70;
Wrist coil ≥ 100.
⑹Two-dimension scan layer thickness

Technical Manual
a. minimum layer thickness 1mm, typical layer thickness 4mm;
b. errors should not more than ±1mm
⑺ Scanning matrixl is 512 x 512;
⑻ Scanning FOV is 128mm×128mm~450mm×450mm;
⑼ Image process
Image width adjust, image level adjust，partial enlarge, digital filter, enhance, measure,
make a note, mark the problem area, region signal test, etc;
⑽ Image storage
Compact disc, etc;
⑾ Image record
Laser camera, or film printer;
⑿ Fat suppression technology, water suppression technology, water image sequence.
14. Basic sequence
⑴ Magnetic correction, RF pulse correction, gradient field correction;
⑵ SE, FSE, GRE, IR, MRA, DWI, ECG-gated sequence, water image sequence, fat
suppression sequence, FLAIR and others.
15. Scanning room
Effective shielding range 5MHz to 130MHz ≥80dB
C.2 Operating environment
Magnetic Resonance Imaging System is I group B type permanent installed medical

equipment. Stability and uniformity of magnet have important effect on MRI image
quality. Temperature control system and air conditioning are needed to ensure the stability
and uniformity of magnet. In scanning room, external magnetic field and external radio
interference signal should be shielded, as well as homoiothermism, constant humidity are
necessary to ensure nice operating environment of the permanent magnetism body and its
work is not interfered by external interference.

Technical Manual
1. Magnet
Temperature (usual) 28℃±0.1℃.
2. Radio frequency shielding room:
⑴ Temperature 22℃±4℃;
⑵ Relative humidity 30% ～75%RH；
⑶ Outside the scanning room, there must be intensive magnetism sign and sign warning
no ferromagnetic material allowed.
3. Equipment room and operation room: temperature 18℃-26℃.
4. Operation Power Supply
3N～400 V, 50Hz, 10KVA (scanning room air conditioning and lighting are not
included).
5. Radio frequency shielding room electromagnetic field shield effectiveness 5MHz to

130MHz ≥80dB.
6. Radio frequency shield room independent earth resistance: <1Ω.
7. Frequency of use: not restricted.
8. Mobility: stationary medical system.
C.3 Packing, transportation and storage
Packing , transport and storage condition for the magnet:

Temperature: -40 °C to + 50 °C;
Humidity: 20% to 90% RH;
Atmospheric pressure: 50.0 kPa to 106.0 kPa.
Packing , transport and storage condition except the magnet:

Temperature: -10 °C to + 55 °C;
Humidity: 20% to 90% RH;
Atmospheric pressure: 50.0 kPa to 106.0 kPa.

Technical Manual
There might be projecting effect around magnetic field. To prevent

threat to magnetic body and personal safety from ferromagnetic
projectiles, the transportation of magnetic body should be handled or
instructed by our technologist. Please refer to the relevant safety notice.
Magnetic body weight is 27000Kg at least; please note the reliability of
lifting tools. And the base strength for magnetic body should be
affirmed in advance!
1.Package
(1) Magnet, diagnostic bed assembly, console, coil, spectrometer and gradient
amplifier of each product should be packaged in wooden cases, there should have
soft cushion material in the case and fixed in it and make sure it cannot move in
the transportation process.
(2) The wooden cases should have waterproof and damp proof measures, and prevent
the product from natural damage.
(3) Accompanying document should put into the wooden cases after packaged use
barrier material
⑷ wooden case should have logos list as follows:
a. Manufacture &Address
b. Product name and model
c. N.W. and G.W.
d. Volume(length ×width× height)
f. Packing cases number
g. Symbols of “fragile material”, “this way up”, “keep dry”, “temperature limit”, “do
not roll” and so on. magnet package should have symbol of “do not stack”, symbols conform
to the regulation of EN 980:2008, magnet package should have “strong magnet field”
symbol, which conform to the regulation of IEC 60601-2-33, see as the following figures:

Technical Manual
The characters and logos in package cases should make sure clear as time goes by.
2 transport and storage
The product after Subpackage, transport and storage environment of permanent

magnet: temperature -40℃～55℃, humidity 20%～90%; transport and storage
environment of other parts and company processing workshop environment: temperature
-10℃～55℃,humidity 20%～90%. Atmosphere pressure are all 50.0kPa～106.0kPa and in
no corrosive gas and well-ventilated room
The requirement of product transport requirement after Subpackage should according

to the regulation of purchase contrast.

Technical Manual
Part D
System hardware explanation
◇ System hardware overview
◇ Magnet
◇ Spectrometer
◇ Gradient amplifier and gradient coil
◇ Transmitting and receiving system
◇ Magnet automatic constant temperature system
◇ Console
◇ Patient table and enclosure
◇ RF shield room (optional fittings)
D.1 System hardware overview
Permanent magnet generates main magnetic field with 0.50T intensity. Three gradient coil
X, Y, Z can set up a X, Y, Z 3D gradient magnetic field greater than 10mT/m. System
main computer controls spectrometer to transmit gradient and generates radio pulse with
magnetic resonance frequency, which will be transmit through radio frequency coil. After
amplifying, frequency mixing, filtering, A/D transforming, the received signals by radio
frequency coil will be transformed into 2D or 3D with Fourier method, image
reconstruction, digital filtering, smoothing, sharpening and other treatment, dislocation
scanning image is acquired.
The system mainly consists of magnet, spectrometer, gradient amplifier, magnet automatic
constant temperature system, enclosure, patient table, console and others (as figure D.1-1
show). Magnet system includes magnet, gradient coil, plane transmitting coil, receiving
coil. Spectrometer consists of host computer, control box, spectrometer unit, radio

Technical Manual
frequency amplifier, power supply and others. Gradient amplifier will amplify X, Y, Z
three-way gradient signals from the spectrometer. Console includes image monitor,
two-way voice transmission system and other auxiliary facilities.
Scan room
Figure D.1-1 System sketch
1. Magnet system 4.Console
2. Spectrometer 5. Air conditioner (arranged by user)
3. Gradient amplifier 6. Power supply system
D.2 Magnet
1. Function
Magnet is the critical component of Magnetic Resonance Imaging System, it provides a

sufficient uniform static magnetic field within imaging space. Uniformity and stability of
the magnetic field must be guaranteed to acquire high quality images.
2. Structure
Magnet adopts C-shaped structure, consisting of frame, polar plate, eddy current free bed,
Nd-Fe-B magnet, shimming ring and shimming small magnetic sheet and others. Function
of the frame is to form a closed magnetic circuit, and works as braced frame of the main
magnet；polar plate make the magnetic field in uniform distribution hence to improve its
magneto-conductivity; eddy current bed is used to obstruct eddy current generated by the
polar plate；Nd-Fe-B magnet(containing neodymium, iron and borium) generates stable
static magnetic field；To improve the magnetic field uniformity, a lap of shimming ring is

Technical Manual
placed around the polar plate and some small magnetic sheets with different size are stuck
on the polar plate.
3. Specs
⑴ Open type, self-constant temperature permanent Nd-Fe-B magnet;
⑵ The main magnetic field strength is 0.50T±5%;
⑶ Magnetic field uniformity
⑷ Magnetic field stability should be no bigger than 10ppm/h;
⑸ Dissipation magnetic induction
At 2.5m distance to permanent magnet center, no bigger than 0.5mT in horizontal

direction；
At 2.5m vertical distance to permanent magnet center, no bigger than 0.5mT in vertical
direction;
⑹ Weight is 27000Kg.
4. Spatial distribution of surrounding field in plots relating to a typical installation of the

MR EQUIPMENT.

Technical Manual
Horizontal distribution of RF field
Vertical distribution of RF field

Technical Manual

Technical Manual
Magnetic field distribution map
Interaction between MRI equipment and peripheral equipments
5. For the safe and efficient magnetic resonance equipment operation, it is necessary for
doctors and operator training. Training should include emergency operating procedures,
covering the terms of the issues involved the following parts:
⑴ emergency medical procedures

Technical Manual
⑵ controlled access area
⑶ fire protection
6. Daily maintenance of magnet
Environment temperature at the normal running conditions should be 22℃±4℃.
D.3 Spectrometer
Spectrometer consists of the following devices:
◇ industrial PC
◇ control box
◇ spectrometer unit
◇ RF amplifier
◇ power supply
They are assembled in a standard cabinet. The devices mounting explanation in the
spectrometer cabinet is given as figure D.3-1 shows. And the inside electrical continuity is
given as the figure shows.
Industrial PC
Control box
Spectrometer unit
RF amplifier
Power supply
Figure D.3-1 Spectrometer assembly sketch

Technical Manual
D.3-1 Industrial PC
Industrial PC controls the routine work of the whole MRI system through its man-machine
interface as the following configuration:
1. CPU ≥2800MHz;
2. operating system: Windows;
3. memory ≥2048MB;
4. hardisk ≥160GB;
5. optical disk RW ;
6. SVGA display card resolution ≥1680×1050dpi;
7. network card: 100Mbps/1000Mbps;
8. image monitor ≥22＂, brightness: 250CD/m2, type: LCD ;
9. system software: permanent magnet MRI system software V4.0.
D.3-2 Control box
Control box provides systematic self-calibration voltage and control signal, transmits 36V
AC power supply required by the receiving unit and 5V DC power supply required by
laser positioning system and two-way voice transmission system, and fulfill the switch of
radio-frequency input signals.
The phase inverter processed the one-way gated signals outputted by spectrometer, and
output positive and negative two-ways gated signals, they are provided to the RF coil
head-end box and RF amplifiers for the signal controlling
D.3-3 Spectrometer unit
Spectrometer is one of the critical components of MRI system. As per impulse sequence
parameters provided by the computer, it generates sequence impulse and output them to
gradient amplifier and radio frequency amplifier for power amplification, and start data
gathering for coil received MR signal after amplification. Then send the data to the
mainframe for raw data treatment and image reconstruction and display.

Technical Manual
1. Digital spectrometer structure
Using full-digital spectrometer, the system consists of two parts, one is the host PC, the
other is spectrometer cabinet. In addition to the main computer itself, there are three
different functional boards, the boards are connected by computer PCI bus. There are six
different functional boards in spectral instrument box. The spectrometer and host
computer are connected by DVI cable and DB15 cable in external standard.
Digital spectrometer system structure

2. The host PC
Description of the functional board in host PC:
MR30990DB : Data Receiver. Processing the 4-channel MR receiver signal form the
MR3410.
MR3090PN: mainly used for high-speed pulse programmer digital signal array processing.
MR3081: gradient and RF waveform generator and pre-emphasis and B0 compensation.
Computer Configuration: Windows2000/XP/NT, CPU ≥ 2.4GHz, Memory ≥ 512MB,

Technical Manual
Hard disk ≥ 80GB

Spectrometer Box Connection: standardsdual-link DVI cable, DB15 cables.
Software: System installation software package: installing driver program.
Test program package: test system.
Demo program: to provide secondary development routines.
Secondary development package: provide the secondary development of drive subprogram,
which can be added to the user’s program to control systems.
3. Spectrometer instrument cabinet:

Description of the functional board in spectrometer cabinet:
MR3082: interface board.
MR3410: Includes two-way transmitting RF channel and four-way TTL gating signal.
MR3420: Supports for 4-channel RF receiver, and it can also expand to 32 channels as
request.
MR3083: 3 pcs of provide three-way gradient analog signal outputs (X, Y, Z). it can also
add another one corresponding the B0 output, the system is not used at present.
Power modules: provide the power supply for the all of the functional boards in the
spectrum cabinet.
Power Supply: single phase ac 100 ~ 240V 50 ~ 60Hz.
Power: Max. 130W.
INTERLOCK: chain plugs, you can take an emergency shutdown spectrometer output
signal, such as RF, gradient. It usually connected with a short plug.
4. Performance parameter
⑴ Spectrometer parameters
0.15MHz to 150MHz
Frequency range Optional: continuous changeable 0.5MHz to
600MHz
Tuning range ± 1.0MHz
maximum frequency bandwidth 400kHz, choosable 1.6MHz

Technical Manual
phase/frequency correction time ≤ 1µs
sampling rate 14 bit, 80 M/s
Data transfer rate (from Rx to

19.6Mbits /each receiver per second
host)
effective sampling 400KHz, 18 bit: 100KHz, 19 bit
accepted SNR ≥90 dB Minimum gain, 100 KHz bandwidth
time resolution 100 ns
RX: +36 dB to -15 dB in 0.1dB steps

attenuation/gain control
TX: +45dB in 0.1 dB steps
digital filter bandwidth 250Hz ～400KHz
transmitting channel 2
Receiving channel 4
RX recovery time < 10us
⑵ Gradient waveform generator
Channel number 3 gradient modules

waveform memory 128K primary/secondary
Sequence memory 64K instructions
matrix multiplication primary 3x3；secondary 3x3
0.2ms to 900ms time constant
Pre-emphasis
6 time constants per gradient channel
0.2ms to 900ms time constant
B0 compensation 9 time constants (3 time constants per gradient
channel )
analog output ±10V 20 differential d/a converters
switch output rate 1µs
⑶ RF waveform generator:
Number of Channels At least 2

Waveform memory 256K

Technical Manual
FM ±999999Hz in 1Hz steps

PM 0- 359.775 degree in 0.225 degree steps
AM ±12 bit , amplitude±1bit
Output Update Rate 2µs
Output power +10dBm 50 Ohm
4. Spectrometer panels
Front-panel
Rear panel

Technical Manual
MR3620 receiving board
MR3610 transmitting board
MR3600 control board
5. Spectrometer control software
For the spectrometer control software, all the parameters were be set by manufacturer,

Technical Manual
users not need to modify them, any modifications by users are forbidden.
D.3-4 Radio frequency amplifier
High voltage exists in the radio frequency amplifier, which can cause
grievous injury on human body, even death. Non- professionals are
forbidden to open the cabinet at any excuse. For professionals, they
must switch off the radio frequency amplifier main power and then
wait for at least 5 minutes to confirm that high voltage assemblies
have been discharged off before open the cabinet!
1. Performance
The amplifier uses the latest generation of solid-state devices in the patented topology
found in thousands of MRI installations worldwide. It zooms in the RF pulse which
outputted by spectrometer.
2. Outside view
Front panel

Technical Manual
Rear panel
3. Performance parameters
⑴ frequency characteristics
center frequency and range 21.30MHz ± 500KHz (0.5T)
gain flatness ± 0.5dB or less (50Ω system)
⑵ Rated input and output power
rated output 5KW (67.0dBm, PEP)
rated input 0dBm
⑶ Power supply
voltage Single phase AC230V±10%

50/ 60Hz
Frequency and current
Maxmum current 20A
surge current Less than 100A
⑷ Cooling method：air cooling
⑸ Operating conditions：
Temperature 10℃～ 60℃
Humidity 20% ～ 90%
Magnetic fields ≤20 Gauss
3. Status indicator and Reset
FUNCTIONAL
yellow Significance
INDICATION
HEAT yellow Thermal protection
PULSE yellow Pulse width protection
DUTY yellow Average power protection

Technical Manual
LOAD yellow Peak power protection

Voltage standing wave ratio
VSWR yellow
protection
On when the main breaker is
Power green turned on, indicating the
standby power is active
Led is blink when start-up
the system, and LED will not
Standby green
blink when turn off the
system
Come on when system is in
Ready green
run code
Equipment fault/ overload
condition. Shut down internal
circuitry until RESET
Fault yellow manually or through Remote
interface. Refer to the system
error codes for specific
condition.
Blinking indicating the start
Diagnostic yellow
up process
Gate green Indicating the gating signal
Turn on RESET when fault
Reset
or overload happens
D.4 Gradient amplifier and gradient coil
◇ gradient amplifier
◇ gradient coil
D.4-1 Gradient amplifier
High voltage exists in the gradient amplifier, which can cause grievous injury on
human body, even death. Non- professionals are forbidden to open the cabinet at
any excuse. For professionals, they must switch off the gradient amplifier main
power and then wait for at least 5 minutes to confirm that high voltage assemblies have been
discharged off before open the cabinet!
The gradient amplifier divided to X, Y, Z.

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Technical Manual

Product name: Magnetic Resonance Imaging System

Basda Magnetic Resonance Imaging System

7. Do not change the installation order.

10. Please use Basda MRI system CD provided by Basda.

6 General warning sign

7 Follow instructions for use

8 Type B applied part

Authorized representative in the European

CE marking, “xxx” is the code of CE notified

20 Warning; laser beam

21 Warning（Risk is middle level）

DISPOSAL: Do not dispose this product as

Technology index and environment requirement C

System hardware explanation D

System software illustration E

Installation and debugging F

Optional fittings and subassemblies G

Manufactory’s declaration for Magnetic Resonance

Imaging System---BTI-050 under standard EN 60601-1-2 I

Product Summary ........................................................................................................ 1

A.1 System principle .................................................................................................................. 1

Product Safety ............................................................................................................ 16

B.1 Criteria of safety requirements .......................................................................................... 16

Technology Index and Environmental Requirement ............................................. 37

C.1 Main technology index ...................................................................................................... 37

System hardware explanation ................................................................................... 49

D.1 System hardware overview................................................................................................ 49

System Software Illustration ..................................................................................... 77

E.1 Brief Introduction .............................................................................................................. 77

Optional Fittings and Subassemblies ..................................................................... 119

Circuit Diagram ....................................................................................................... 120

Manufacturer’s declaration for Magnetic Resonance Imaging System---BTI-050

◇ System principle ◇ System usage

◇ Indication & contraindication

◇ Nominating method, model of the system

◇ Classification of the System ◇ Constituents of the System

◇ Basic parameter and performance

◇ System working conditions and service life

◇ System operating mode ◇ Patient support

A.1 System principle

Magnetic Resonance Imaging technology utilizes magnetic resonance phenomena to

Basda Magnetic Resonance Imaging System Page 1 of 128

A.2 System usage

A.3 Indication and contraindication

Main contraindication of the system:

1. Patients with electrocadiac pace-maker;

2. Patients bearing insulin pump；

3. Patients with ferromagnetic metal hemostatic clamps in vivo;

4. Patients bearing metalic, magnetic blood vessel bracket；

5. Patients in emergent illness and not suitable for MRI examination；

6. Patients in early pregnancy within 3 months.

Basda Magnetic Resonance Imaging System Page 2 of 128

Patients mentioned above are strictly prohibited to take MRI

A.4 Nominating method, model of the system

BTI-XXX Magnetic Resonance Imaging System

Model (BTI enterprise code; XXX design serial number, indicated as

2. Model and name

BTI-050 Magnetic Resonance Imaging System.

A.5 Classification of the system

1. According to the type of protection against electric shock, it is class I equipment.

3. According to the degree of protection against harmful ingress of water, it is ordinary

4.According to the manufacturer allowed sterilization type, it is sterilization equipment.

5. According to the degree of safety of application in the presence of a FLAMMABLE