SIUI SR-8210 User manual

SSNCXALV110ENA
SR-8210
Portable X-Ray Unit
OPERATION MANUAL

Statement
Statement
1. This Operation Manual contains warnings and attentions/ cautions regarding
foreseeable potential dangers. Be vigilant at all times about those illustrated dangers.
The company is not responsible for any damage or loss caused by negligence or
disregard of the precautions specified in this Operation Manual.
2. Use the device only under the guidance of a qualified medical professional or a
qualified medical professional.
3. The company does not take any responsibility for the loss of data stored in the device
due to the operator's mistake or abnormal situation.
4. The doctor is responsible for the diagnosis process, and the company is not
responsible for the diagnosis process.
5. After purchasing the device, the user is fully responsible for the maintenance and
management of the device.
6. The company is not responsible for the safety, reliability and performance of the
device if:
1) Damage or loss caused by improper operation or rough use.
2) Damage or loss caused by Force majeure such as fire, earthquake, flood or
lightning.
3) Failure to comply with the conditions for use of this device, such as damage or
loss caused by insufficient power supply, incorrect installation, environmental
conditions that do not meet requirements, or related electrical equipment used
does not meet national standards.
4) Damage or loss caused by using the device in the area where it was originally
purchased.
5) The assembly operation, expansion, readjustment, improvement and repair of
the device are not performed by personnel approved by the company.
6) Damage or loss caused by the device not purchased from the company or its
authorized distributors.
7. The company shall be responsible for accuracy and integrity of this Operation Manual.

Statement
8. The company reserves the final right to interpret this Operation Manual.

Service Instruction
Service Instruction
1. SIUI will provide free service if failure happens under normal usage by obeying the
operation manual during the warranty period.
2. No free service will be provided in the following condition.
1) Expiration of warranty period.
2) Failure caused by abnormal usage (such as abnormal supply voltage, fire, man
error accident and so on).
3) Disassembly and repair are performed by persons not authorized by SIUI.
4) System damage caused by disassembly not authorized by SIUI, in this situation,
SIUI has the right to refuse to provide service.
SIUI will charge for the service, if the system expires the warranty period.
Contact Information of SIUI Service
Address: Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
77 Jinsha Road, Shantou, Guangdong 515041, China
Tel: [phone] Fax: [phone]
E-mail: [e-mail] or [e-mail]

Contents
I
Contents
Preface.............................................................................................................................. IV
Chapter 1 GENERAL.............................................................................................1-1
1.1 Application Scope..................................................................................................1-1
1.2 Product...................................................................................................................1-1
1.3 Indications for Use.................................................................................................1-1
1.4 Specifications.........................................................................................................1-1
1.5 Composition and Meaning of Model......................................................................1-2
1.6 Environmental Conditions......................................................................................1-2
1.7 Power Requirement for Normal Operation............................................................1-2
1.8 Impact to Environment and Energy.......................................................................1-3
1.9 Classification..........................................................................................................1-3
1.10 Safety.....................................................................................................................1-3
1.11 ESSENTIAL PERFORMANCE..............................................................................1-4
Chapter 2 PRECAUTIONS FOR SAFE USE............................................................2-1
2.1 Safe Use Period, Manufacture Date and Validity..................................................2-1
2.2 General Rules for Safe Use...................................................................................2-1
2.3 Common Wrong Use or Operation........................................................................2-2
2.4 Possible Damage due to Wrong Use or Operation...............................................2-2
2.5 Emergent Action for Abnormal Situation...............................................................2-2
2.6 Precautions in Special Cases (Power Failure, Transport)....................................2-3
2.7 Electrical Safety.....................................................................................................2-3
2.8 Radiation Safety.....................................................................................................2-3
2.9 Contraindications...................................................................................................2-4
2.10 EMC Safety............................................................................................................2-4
2.11 CyberSecurity Instruction Safety...........................................................................2-4
Chapter 3 COMPOSITION AND OPERATION PRINCIPLE....................................... 3-1
3.1 Composition...........................................................................................................3-1
3.2 Operation Principle ................................................................................................3-1

Contents
II
3.3 Accessories............................................................................................................3-4
3.4 Option.....................................................................................................................3-4
Chapter 4 SPECIFICATIONS ..................................................................................4-1
4.1 Specifications of Portable X-ray Unit.....................................................................4-1
4.2 Specifications of X-ray Tube..................................................................................4-2
4.3 Typical Exposure Technique Factors Setup for Reference...................................4-7
4.4 Dimension and Weight...........................................................................................4-7
Chapter 5 DEVICE INSTALLATION.........................................................................5-1
5.1 Device Connection.................................................................................................5-1
5.2 Connection with Imaging Device...........................................................................5-2
Chapter 6 USE AND OPERATION...........................................................................6-1
6.1 Operation................................................................................................................6-1
6.2 Power On/Off.......................................................................................................6-11
6.3 How to Use Exposure Hand Switch.....................................................................6-11
6.4 How to Use Collimator.........................................................................................6-14
6.5 Program Update...................................................................................................6-15
6.6 Li-ion Battery........................................................................................................6-16
6.7 Use of exposure remote control ..........................................................................6-19
Chapter 7 SAFETY PROTECTION DEVICE AND TROUBLESHOOTING ................. 7-1
7.1 Safety Protection Device and Precautions............................................................7-1
7.2 Procedure and Method to handle failures .............................................................7-1
7.3 Emergency Measures............................................................................................7-1
7.4 Failure Analysis and Troubleshooting...................................................................7-1
7.5 Replaceable components list.................................................................................7-5
Chapter 8 MAINTENANCE .....................................................................................8-1
8.1 General Maintenance.............................................................................................8-1
8.2 Maintenance in System Running...........................................................................8-1
8.3 Regular Maintenance.............................................................................................8-1
8.4 Calibration Instruction.............................................................................................8-2
8.5 Quality Assurance..................................................................................................8-4

Contents
III
8.6 Cleaning and disinfection.......................................................................................8-5
8.7 Environmental Protection Requirements ...............................................................8-6
Chapter 9 STORAGE, TRANSPORT AND PACKAGE ............................................. 9-1
9.1 Storage and Transport...........................................................................................9-1
9.2 Package Symbols...................................................................................................9-1
9.3 Unpacking and Check............................................................................................9-1
Appendix A Description of Symbols......................................................................A-1
Appendix B Guidance and Manufacturer’s Declaration.........................................B-1
SSNCXALV110ENA

Preface
IV
Preface
To use this portable x-ray unit (“system”, “machine”, “device” or “unit”) correctly and
safely and to ensure a long operation life, the user should thoroughly understand the
device performance, functions, operations and maintenance. Please read this operation
manual carefully before using the device.
This device has been designed and manufactured with operator and patient safety
considered. However, to ensure reliability and safety when using the device, please pay
attention to the following instructions:
a) This device should be operated only by or under the guidance of a qualified
person.
b) Please follow placement requirements to place the device properly. Do not place
any liquid that might be spilled out near the machine.
c) To avoid danger of leakage, never try to modify the device or remove the
enclosure without our explicit permission. If modification to the device is required,
contact our agent or us for assistance.
d) The device has been well adjusted before delivery. Do not try to readjust any
adjustable parts that have been fixed.
e) If any abnormality, such as abnormal noise, smell, smoke, temperature rise or
leakage, is found, cut off the power supply immediately. Then contact our agent
or us for help. Do not try to repair the device by yourself.
f) If the device is not in use for a long time, please disconnect the power plug.
g) The device installation, maintenance and repair shall be performed by a
professional person from the manufacturer or a qualified person received
professional training.
h) This Operation Manual may be slightly different from that of your equipment due
to device software version, as well as configuration of options and accessories.
The actual device that you purchase shall prevail.
i) Pay attention to DANGER, Warning or Caution on the operation manual, please
read carefully and work discreetly.

Preface
V
【DANGER】: Identifies a situation or operation that is known to be a particular
hazard. Failure to follow this instruction could result in severe casualties or
significant property damage.
【Warning】: Identifies a situation or operation that is known to be a particular
hazard. Failure to follow this instruction could result in serious personal injury or
property damage.
【Caution】: Means potential danger, in order to avoid mild or moderate personal
injury or loss.
j) If the administrator of this device changes, this Operation Manual shall be
handed over so that new administrator can properly manage this device and
avoid damage or loss due to improper operation.
k) The company reserves the right to update any information in the Operation
Manual without notice. Please contact us for technical support.
l) The Operation Manual may be reproduced or reprinted. However, without prior
written approval, not any part of this manual shall be quoted.
All pictures and texts in this Operation Manual are provided according to the latest version
at the time of publication. Due to improvements or other changes, the descriptions in this
Operation Manual may differ slightly from the actual situation, and the Company shall
retain the right to modify it without notice. For technical support, please contact the
Company. This Operation Manual may not be quoted in any part of without our prior
written permission.
Revision Date: December. 2021

General
1-1
Chapter 1
General
1.1 Application Scope
This device is a portable X-ray unit with internal power supply. Compared with traditional
X-ray products, this device has exquisite structure, compact design, light weight and easy
operation. It is designed for X-ray imaging and diagnosis in medical facilities when used
with an X-ray imaging device.
1.2 Product
a) Exquisite structure, compact design and light weight.
b) Microcomputer intelligent control, high accuracy of loading parameters.
c) High working frequency and long battery life.
d) MultipleAPR storage.
1.3 Indications for Use
The SR-8210 Portable X-ray Unit is a portable X-ray device, intended for use by a
qualified/trained physician or technician for the purpose of acquiring X-ray images of the
desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen,
lumbar spine, pelvis and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
-The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar
spine, pelvis or extremities.
-The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
1.4 Specifications
a) The output power of portable X-ray unit is 3.2kW

General
1-2
b) The output voltage of portable X-ray unit is 40-125kV
c) The output current of portable X-ray unit is 10-80mA
d) The small tube focus is 0.6mm.; The big tube focus is 1.8mm
1.5 Composition and Meaning of Model
SR - 8210
Product model
Product code, with 2 letters (from left to right) referring to:
S- Smart, R- Radiographic X-ray device
1.6 Environmental Conditions
1.6.1 Normal operation conditions
a) Ambient Temperature: 10℃～40℃.
b) Relative Humidity: 30%～75%.
c) Atmospheric Pressure: 700hPa ～1060hPa.
d) Ambient environment: no strong mechanical vibration and strong
electromagnetic interference, no corrosive gas or dust.
1.7 Power Requirement for Normal Operation
Battery Charger:
a) Rated voltage: 100-240V～;
b) Rated current: 1.2A (max);
c) Operating frequency: 50-60Hz;
d) Output voltage: 50.4V ;
e) Output current: 1.4A;
f) Class II equipment;
The power supply of the portable X-ray unit is internal power supply.

General
1-3
1.8 Impact to Environment and Energy
a) Power-saving technology is used in the device. For example, instead of
a conventional halogen lamp, a high-bright LED is used in the collimator, with the
power only a few tenth of the halogen lamp.
b) The device shall be recycled properly at the end of its shelf life in accordance with
relevant national safety and environmental standards & regulations, so as to
reduce the risks arising to the lowest level.
1.9 Classification
1.9.1 Classification by anti-shock type
The product is a Class I internal power supply device.
1.9.2 Classification by anti-shock degree
The product is a common device of Type B applied part.
1.9.3 Classification by IP rating
The product IP rating is IPX0.
1.9.4 Classification by safe use in the case of flammable anesthetic gas mixed with
air or flammable anesthetic gas mixed with oxygen or nitrous oxide
DO NOT USE THE DEVICE in the presence of flammable anesthetic gas mixed with air or
with oxygen or nitrous oxide.
1.9.5 Classification by operating mode
Continuous operation, intermittent loading.
1.10 Safety
a) The device does not apply to mammography and dental radiography.
b) It is prohibited for the same patient (especially children) to receive high-frequency
imaging of the device for a long period.
c) Pregnant women undergoing X-ray exams may result in fetal injury. Clinicians’
decision shall be made by weighing the condition of patients.

General
1-4
1.11 ESSENTIAL PERFORMANCE
a) The error in the indicated value of the X-ray tube voltage, in any combination of
loading factors, shall be not greater than 10%.
b) The error in the indicated value of the X-ray tube current, in any combination of
loading factors, shall be not greater than 20%.
c) The error in the indicated value of the X-ray tube loading time, in any combination
of loading factors, shall be not greater than ± (10%+1ms).
d) The error in the indicated value of the X-ray tube current time product, in any
combination of loading factors, shall be not greater than ± (10%+0.2mAs).
e) The coefficient of variation of measured values of air kerma shall be not greater
than 0.05 for any combination of loading factors.
【Warning】Despite X-ray harm to humans, the X-ray device will not result in any
danger provided that the operation is correct. Please ensure to meet
safety requirements of the operation. Read each section
of the manual carefully, and fully understand the safety and
operational requirements.
【Warning】If repair and maintenance for the X-
ray device is not performed
in accordance with manufacturer’s requirements, or if there is any
unauthorized alteration of any form, the manufacturer
is not
responsible for any patient or user injury (including over exposure to
X-ray radiation.
【Warning】The duties of the operator are to ensure patient safety during X-ray
device running through visual observation, reasonable posture
placement and actions that intend to prevent patient against injury.
To avoid danger of leakage.
No modification of this equipment is
allowed.
【Warning】To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.

General
1-5
【Caution】The device fundamental performance shall be tested once every year
by contacting SIUI service or a qualified agent.

Precautions for Safe Use
2-1
Chapter 2
Precautions for Safe Use
2.1 Safe Use Period, Manufacture Date and Validity
The device is valid for 10 years. The validity is a safe use period. For manufacture date,
please see the label on the device enclosure.
2.2 General Rules for Safe Use
a) The device shall ONLY be used by medical practitioners with professional
qualification or be used under the guidance of medical practitioners with
professional qualification.
b) Follow the operating requirements in this manual strictly.
c) Use in a protective/shielded room or radiation controlled environment.
d) Use the dose parameter provided by radiologists or diagnostician. Use the dose
that produces the best diagnostic results and the minimum dose for X-ray
exposure.
e) It is necessary to have X-ray protection. During X-ray exposure, the operator
should wear protective clothing and stand behind the lead shield or the lead glass
shield, and other unrelated persons should be kept away from the imaging site.
Time protection: all personnel should minimize the time stayed in the X-ray field.
Distance protection: all personnel shall keep as far away as possible from the
X-ray source.
Shield protection: Doctors and accompanying persons shall use lead products
such as lead gloves, lead clothing and lead glasses or stand behind the lead
glass shield for X-ray exposure.

Precautions for Safe Use
2-2
2.3 Common Wrong Use or Operation
a) Wrong cable connection of the device results in exposure failure.
b) Dose in use not as provided by qualified medical practitioners with professional
qualifications, and the dose value is too high or too low.
2.4 Possible Damage due to Wrong Use or Operation
a) Exposure failure may lead to radiation dose absorbed by patients increase
exponentially.
b) Decreased image quality and impact to diagnosis due to over or under dose, and
the radiation dose absorbed by patients increase exponentially.
2.5 Emergent Action for Abnormal Situation
If any abnormal situation is found when charging, immediately unplug the charger from the
mains supply outlet and disconnect the charger output from the X-ray machine. If any
abnormal situation is found when the X-ray machine is operating, immediately disconnect
the charger output from the X-ray machine, and turn the Rocker Switch at the side of the
device to "OFF" position. Turn on the device only after receiving the confirmation from the
manufacturer or the distributor that it is safe to do so.
【Warning】Users should pay significant attention to X-Ray protection, so as to
prevent themselves or other persons from exposure as a result of
negligence, errors or unawareness.
All authorized personnel to operate the device
shall fully
understand the danger of exposure to X-
ray. It is strongly
recommended that the users should use protective materials and
facilities to prevent against any injury or damage due to X-ray
radiation. Improper use of the X-ray device may result in bodily
injury!

Precautions for Safe Use
2-3
2.6 Precautions in Special Cases (Power Failure, Transport)
In case any damage or failure is found in the device, do not use it before the problem is
fixed by a qualified person.
2.7 Electrical Safety
a) Avoid the device from contact with any electrical conductor, or it may lead to a
risk of electric shock.
b) To ensure safe and reliable device performance, please prepare the site as
required in the operation manual. If you have any questions on the requirements,
please contact us.
c) Device installation, debugging and repair can only be performed by professionals
authorized by the Company.
2.8 Radiation Safety
a) During X-ray exposure, the operator should wear protective clothing and stand
behind the lead shield or the lead glass shield, and other unrelated persons
should be kept far away from the device. All personnel should minimize the time
stayed in the X-ray field.
b) Use the exposure dosage required by the radiologist or the physician, and the
exposure shall be the minimal X-ray exposure for producing the best diagnostic
result.
c) Necessary protection shall be provided for the patient’s body parts not relevant to
the exam. Protection for the medical staff shall be provided as well.
d) Do not calibrate the device if the patient or the operator is near the device.
【Warning】Avoid the device from contact with any electrical conductor, or it may
lead to a risk of electric shock!
【Warning】Risk of exposure to hazardous radiation to the user or patient if safe
X-ray operation is not observed!