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SIUI SR-8210 Operation Manual

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SSNCXALV110ENA
SR-8210
Portable X-Ray Unit
OPERATION MANUAL

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Summary of Contents for SIUI SR-8210

  • Page 1 SSNCXALV110ENA SR-8210 Portable X-Ray Unit OPERATION MANUAL...
  • Page 3 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.
  • Page 4 Statement 8. The company reserves the final right to interpret this Operation Manual.
  • Page 5 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.

  • Page 7: Table Of Contents

    Contents Contents Preface ..........................IV Chapter 1 GENERAL ..................... 1-1 Application Scope ....................1-1 Product ........................1-1 Indications for Use ....................1-1 Specifications ......................1-1 Composition and Meaning of Model ..............1-2 Environmental Conditions ..................1-2 Power Requirement for Normal Operation ............1-2 Impact to Environment and Energy ...............
  • Page 8 Contents Accessories ......................3-4 Option ........................3-4 Chapter 4 SPECIFICATIONS .................. 4-1 Specifications of Portable X-ray Unit ..............4-1 Specifications of X-ray Tube .................. 4-2 Typical Exposure Technique Factors Setup for Reference........4-7 Dimension and Weight ................... 4-7 Chapter 5 DEVICE INSTALLATION ................. 5-1 Device Connection ....................
  • Page 9 Contents Cleaning and disinfection ..................8-5 Environmental Protection Requirements ............... 8-6 Chapter 9 STORAGE, TRANSPORT AND PACKAGE ..........9-1 Storage and Transport ................... 9-1 Package Symbols ....................9-1 Unpacking and Check .................... 9-1 Appendix A Description of Symbols ..............A-1 Appendix B Guidance and Manufacturer’s Declaration .........

  • Page 11: Preface

    Preface 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.
  • Page 12 Preface 【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.

  • Page 13: Chapter 1 General

    Multiple APR 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).

  • Page 14: Composition And Meaning Of Model

    General 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 Composition and Meaning of Model SR - 8210 Product model Product code, with 2 letters (from left to right) referring to:...

  • Page 15: Impact To Environment And Energy

    General 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 &...

  • Page 16: Essential Performance

    General Despite X-ray harm to humans, the X-ray device will not result in any 【Warning】 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.
  • Page 17 General The device fundamental performance shall be tested once every year 【Caution】 by contacting SIUI service or a qualified agent.

  • Page 18: Chapter 2 Precautions For Safe Use

    Precautions for Safe Use Chapter 2 Precautions for Safe Use 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. 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...

  • Page 19: Common Wrong Use Or Operation

    Precautions for Safe Use Users should pay significant attention to X-Ray protection, so as to 【Warning】 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.

  • Page 20: Precautions In Special Cases (Power Failure, Transport)

    Precautions for Safe Use 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. Electrical Safety a) Avoid the device from contact with any electrical conductor, or it may lead to a risk of electric shock.

  • Page 21: Contraindications

    Precautions for Safe Use Despite X-ray harm to humans, the X-ray device will not result in any 【DANGER】 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.

  • Page 22: Cybersecurity Instruction Safety

    Purpose of network connection This system has a network connection function, and data can be transmitted through the USB port of device interfaces from USB disk to the device, which facilitates SIUI engineer to perform program update to the device.
  • Page 23 Users include general users and device maintenance personnel. General users: can operate the essential basic functions of SR-8210. Device maintenance personnel: can operate the basic functions of SR-8210, enter the device engineering menu and view the imaging parameters by entering the password.

  • Page 24: Chapter 3 Composition And Operation Principle

    Composition and Operation Principle Chapter 3 Composition and Operation Principle 3.1 Composition The product is mainly composed of SYS board, KB board, X-ray tube, high-voltage tank, collimator, lithium-ion battery, exposure switch and lithium-ion battery charger. Its structure is shown in Fig. 3-1. Collimator KB board SYS board...
  • Page 25 Composition and Operation Principle Fig. 3-2 System Operation Principle Power Supply and Power-On/Off Circuit The battery module is sent to the inversion module through the capacitance storage module, and the power supply is sent from the battery module to the power supply module (.
  • Page 26 Composition and Operation Principle Principle of Tube Current Loop Control In the exposure process, signals sampled by the current sampling circuit are sent to the SYS board, by which a comparison is carried out between feedback signals and internal reference signals. After the operation, a proper filament heating current reference value is added to the filament heating module, which sends the corresponding current to the X-ray tube filament based on the reference value, resulting in a stable tube current.

  • Page 27: Accessories

    Composition and Operation Principle A self-test of the main unit control device is performed when powering up the device. During the operation, each unit is monitored, and protection action will be done if any abnormal situation occurs. Meanwhile the failure information is sent to the console and failure warning signals are given, with the error code displayed on the kV window.

  • Page 28: Chapter 4 Specifications

    Specifications Chapter 4 Specifications 4.1 Specifications of Portable X-ray Unit a) Charging input voltage: 50.4V b) Input power: battery 44.4V c) Max. output power: 3.2kW @ 100kV, 32mA，125kV, 25mA d) Nominal power: 3.2kW @ 100kV, 32mA, 0.1s e) Adjustable range of tube voltage: 40 125kV, step value 1kV.

  • Page 29: Specifications Of X-Ray Tube

    Specifications p) SID: SID distance 1m in normal use, measured with the tape in the collimator. q) Maximum continuous heat loss: 250W r) Deviation between focus position and reference axis: ± 1° 4.2 Specifications of X-ray Tube 4.2.1 IEC classification: Class I, Type B 4.2.2 Main specifications Electrical parameters Circuit (neutral grounding) ………………………………………………………DC circuit...
  • Page 30 Specifications Fig. 4-1 Thermal Characteristics of Anode 4.2.4 As shown in Fig. 4-2.
  • Page 31 Specifications Fig. 4-2...

  • Page 32: Typical Exposure Technique Factors Setup For Reference

    Specifications 4.3 Typical Exposure Technique Factors Setup for Reference Adult application Distance: SID=1m Parts and aspect Size X-ray tube voltage Current time product Head (PA) Normal 72 kV 12.5 mAs Head (PA) 72 kV 16 mAs Head (PA) Slim 70 kV 12.5 mAs Head (LAT) Normal...
  • Page 33 Specifications Knee (AP) 70kV 6.3mAs Knee (AP) Slim 65kV 4mAs Knee (LAT) Normal 65kV 5mAs Knee (LAT) 70kV 6.3mAs Knee (LAT) Slim 65kV 4mAs Ankle (LAT) Normal 65kV 5mAs Ankle (LAT) 70kV 5mAs Ankle (LAT) Slim 65kV 4mAs Foot (AP) Normal 50kV 3.2mAs...

  • Page 34: Dimension And Weight

    Specifications 4.4 Dimension and Weight a) Dimension of portable X-ray unit (L× W × H): 460mm×245mm×188mm Weight: 13kg. See Fig. 4-3. Fig. 4-3 b) Case dimensions (L× W × H): 530mm×290mm×285mm Weight: 6kg. See Fig. 4-4. Fig. 4-4 The glass tube and digital receptor module in the device are valuable 【Warning】...

  • Page 35: Chapter 5 Device Installation

    Device Installation 5.1 Device Connection Take the SR-8210 out of the case, and insert the red wire of the exposure hand switch as indicated in Fig. 5-1 to the “HAND SWITCH” exposure hand switch port on the rear cover of the portable X-ray machine. The red marks on both ends shall be connected easily.

  • Page 36: Connection With Imaging Device

    Device Installation 5.2 Connection with Imaging Device If a film cartridge or a similar imaging device is used for image acquisition directly, the device installation is finished. Follow the operation instruction to work. When using this device to connect a digital flat panel detector, first 【Caution】...

  • Page 37: Chapter 6 Use And Operation

    Use and Operation Chapter 6 Use and Operation 6.1 Operation 6.1.1 Operation Buttons and Functions Fig. 6-1 Control Panel Control Part Type Functional Description Exposure Level 1 Ready Indicator When using the exposure hand switch, long press the hand switch Level 1, till the Exposure Level 1 READY Indicator is on.
  • Page 38 Use and Operation indicator turns on and the X-ray machine makes a "Di" sound. Wait for READY turning on. Exposure Indicator When using the hand switch, long press the Exposure Level 1. When the Exposure Level 1 Ready Indicator is on, Long press the Exposure Level 2.
  • Page 39 Use and Operation indicator lights up; when the portable X-ray machine wireless is not connected, the indicator flashes; when the portable X-ray machine wireless function is turned off, the indicator does not light up. kV Parameter Display Digital Tube This digital tube is used to display the value of Digital Tube exposure parameter kV.
  • Page 40 Use and Operation patient posture, body type and exposure angle for imaging. When pressing the APR button, the corresponding indicator is on and the exposure parameters set by the manufacturer or user will be displayed on the digital tube. Long press APR8 to adjust mA.
  • Page 41 Use and Operation exposure mode. The exposure mode will be displayed on the mAs digital tube, 1 for Level1 (one-press) exposure Level2 (two-press) exposure. 6.1.2 Imaging Function Area a) Toggle the rocker switch on the back cover of the portable X-ray machine to "ON" and press button, and the device will display “8”...
  • Page 42 Use and Operation adjust mA. When mA is adjusted, the power will not exceed the maximum output power of the device, and the device will intelligently recognize the limit. APR1～ APR8 cannot be adjusted in mA adjustment mode. After mA adjustment is completed, long press APR8 to return to display the exposure parameters of kV and mAs.
  • Page 43 Use and Operation relevant error or device error; and the tube is ready for exposure. When is on, it means X-ray is emitting, and the sound of exposure indication can be heard in the exposure. The selected exposure parameters are displayed on corresponding 【Caution】...
  • Page 44 Use and Operation Restore factory Menu No. Menu Menu Function defaults correct the window; and the mAs window displays filament value the current corrected Kv/mA parameter combination in turn. Restore to factory settings, including the imaging parameters of APR, tube Reset filament value, and feedback control time of kV.
  • Page 45 Use and Operation Restore factory Menu No. Menu Menu Function defaults shutdown to operation. The default value is 30 poweroff minutes. The value can be adjusted in the range 【0, 120】 at the increment of 1 minute. When it is adjusted to 0, the timing limit is not performed.
  • Page 46 Use and Operation Restore factory Menu No. Menu Menu Function defaults 192.168.8.199 Device 2: 192.168.8.200 Device 3: 192.168.8.201 Device 4: 192.168.8.202 The default value of the remote port is When P40 is 0, modify the 18100. communication port in the DR system The local ports mode and press APR1-5 to switch Modify remote...

  • Page 47: Power On/Off

    Use and Operation Restore factory Menu No. Menu Menu Function defaults working mode 2 is high voltage generator mode. Intelligent Valid when P40 is 0, and the wireless distribution connection configuration operation in network this mode. Change AP The default is Mode Valid when P40 is 2.
  • Page 48 Use and Operation indicator goes off, and the X-RAY indicator turns on till the end of exposure (the COMPLETE indicator turns on). Release the hand switch button at either level, you may finish the current operation. Standby Level 1 (READY) Level 2 (X-RAY) Fig.
  • Page 49 Use and Operation exposure is triggered, the exposure countdown is entered, the exposure delay is 0 to 60 seconds, the default is 5 seconds, 0 is no delay, that is, the second press of the exposure button will perform the exposure immediately, the exposure light is on; if it is not 0, the exposure is triggered, the READY indicator flashes at a delay time of 3 times per second till completion, and the exposure starts at the end of the READY time.

  • Page 50: How To Use Collimator

    Use and Operation the back of the portable X-ray machine is OFF. d) To protect the X-ray machine, the intelligent temperature control system will have certain control during exposure. If continuous exposure is performed when mAs≥30, the time interval after each exposure will increase. Now stop the exposure operation and have a break for a few minutes;...

  • Page 51: Program Update

    Use and Operation If the current exposure is completed normally, the collimator radiation field indicator is turned off automatically. b) The ruler at the bottom of the collimator is for measuring and deciding SID distance, and for measuring thickness of the measured portion. c) Here is the light field inspection of the collimator: keep the portable X-ray machine horizontally, pull out the measuring ruler to 65cm, and vertically stand a...

  • Page 52: Li-Ion Battery

    Use and Operation Fig. 6-7 USB port on the back cover If the kV digital tube displays "888" when the update fails, check the USB disk to see if it contains the update program, and if the name of the update program is correct. After confirming the above, repeat the above steps and wait for the system to finish the automatic update.
  • Page 53 Use and Operation Pick piece Fig. 6-8 Fig. 6-9 6.6.2 Power requirements for charger Indicator: Yellow for disconnection or slow charge, or Orange for fast charge, and Green for full charge. Use the charger manufactured and configured by the company only. 【Caution】...
  • Page 54 Use and Operation recharge. a) As shown in Fig. 6-10, make sure the power switch is toggled to "OFF" state, otherwise the battery cannot be charged even if the charger is connected. b) Insert the output terminal of the charger into the battery in port at the device back, and connect the charger to the mains.

  • Page 55: Use Of Exposure Remote Control

    Use and Operation local laws and regulations or national standards. g) The discarded battery shall be safely disposed of, otherwise there might be a danger of explosion or fire. h) Do not discard or disassemble the used battery, otherwise it may result in unnecessary danger, such as an explosion or fire.
  • Page 56 Use and Operation Fig. 6-11 Press the "A" key (Ready) Press the "B" key (Expose) Fig. 6-12 a) Wait for 5s between two consecutive exposure operations, 【Caution】 otherwise normal exposure cannot be performed. b) Failure to follow the instructions may result in exposure failure.
  • Page 57 Use and Operation Standby state. You can change the time for P6 “Standby time” and P21 ”Timing setting from shutdown to poweroff” in Engineering Mode in 6.1.3 "Engineering Mode Function and Operation". d) There is an icon in the upper right of the portable X-ray machine for power display.

  • Page 58: Chapter 7 Safety Protection Device And Troubleshooting

    Safety Protection Device and Troubleshooting Chapter 7 Safety Protection Device and Troubleshooting 7.1 Safety Protection Device and Precautions Fuse: to avoid overcurrent, short circuit, and battery burn. Temperature control switch: to protect the tube core. Over-current protection circuit To determine if over current occurs by monitoring battery capacity change when exposure.
  • Page 59 Safety Protection Device and Troubleshooting The device has a failure self-test function. If any key failure occurs, the device will give alarm, which facilitates failure inspection and troubleshooting. Generally, the first step to confirm a failure is to check if the voltage of the power supply is normal, and check all circuit boards for any failure.
  • Page 60 Safety Protection Device and Troubleshooting Error Failure Description and Cause Troubleshooting Code Analysis Abnormal parameters tube Press Fn to clear the code. If the error voltage self-check in standby state still exists, turn off the system and contact the manufacturer for repair. Press Fn to clear the code.
  • Page 61 Safety Protection Device and Troubleshooting Error Failure Description and Cause Troubleshooting Code Analysis Fail to export the E09 error error code will cleared parameters to the USB disk during automatically after flashing for 1 second. the program update. Fail to export the E16 error error code will...

  • Page 62: Replaceable Components List

    Safety Protection Device and Troubleshooting Error Failure Description and Cause Troubleshooting Code Analysis The USB disk was detected during Press Fn button to exit the update. software update, but the data on the USB disk fails to be read (e.g. USB write protection or broken USB disk) Software update failed.

  • Page 63: Chapter 8 Maintenance

    Maintenance Chapter 8 Maintenance Regular maintenance can ensure that the device runs continuously and safely. Meanwhile with improved maintenance, damage (such as device downtime and repair) is reduced, and safety performance (personal injury) is improved. 8.1 General Maintenance The power must be switched off before starting maintenance. When the entire system is in working condition, do not try to clean any part of it.

  • Page 64: Calibration Instruction

    8.4 Calibration Instruction 【Caution】: This operation requires the X-ray unit to be tested in a protective room! The calibration procedure for the SR-8210 requires special tools and should be done by SIUI trained technicians only. Tools required： •...
  • Page 65 Maintenance aluminum sheet of the X-ray output, press the exposure hand switch level 1, make sure the filament at the X-ray output is turned on normally, and then release the hand switch. 【Caution】: Before exposure, the operator should make sure that the shielded room is closed.

  • Page 66: Quality Assurance

    【Caution】: The number of filament values being adjusted each time shall not exceed 3. 8.5 Quality Assurance The following quality control inspections shall be trained and provided service by SIUI qualified engineers. The device has no cosmetic damage. The connection surface of the whole device...

  • Page 67: Cleaning And Disinfection

    If step e) fails to comply with the relevant essential performance requirements, please contact SIUI immediately, and SIUI’s qualified engineers are available for service. The items packed in the package carton shall match the items listed in the packing list in terms of models and quantity.

  • Page 68: Environmental Protection Requirements

    Maintenance When cleaning, make sure the device is powered off, and prevent water or cleaning liquids from entering the device, otherwise it might cause device damage. Do not remove the device enclosure, and do not disassemble or 【Caution】 modify any parts inside the device. Such actions may result in serious personal injury and device damage! When the device is powered up, DO NOT clean any part of the 【Caution】...

  • Page 69: Chapter 9 Storage, Transport And Package

    Storage, Transport and Package Chapter 9 Storage, Transport and Package 9.1 Storage and Transport a) Ambient temperature: -20 ℃～55 ℃ b) Relative humidity: ≤ 93% c) Atmospheric pressure: 500hPa ～ 1060hPa d) No corrosive gases, good ventilation Indoors e) Transport requirements are as required by the contract, and package symbols are compliant to requirements.
  • Page 70 Storage, Transport and Package c) The unit should be placed in the direction according to the carton symbol. Do not reverse the direction. d) Storage environment requirements: Temperature -20℃～55℃, rel at i ve hum i di t y ≤93%, no source of corrosion, or strong power supply. e) Clean indoor environment with heat source.

  • Page 71: Appendix A Description Of Symbols

    Description of Symbols Appendix A Description of Symbols Symbol IEC publication Description IEC 60878-5007 "ON" (power) IEC 60878-5008 "OFF" (power) IEC 60878-5009 Connected and stand-by IEC 60878-5031 Direct current IEC 60878-5032 Alternating current IEC 60878-5172 Charger: Class II equipment —— Indoor use only IEC 60878-5384 Light Indication of radiation field...
  • Page 72 Description of Symbols Symbol IEC publication Description IEC 60878-5909Pr Symbol of ionizing radiation IEC 60878-5840 Type B applied part IEC 60878-ISO Follow instructions for use 7010-M002 ISO 15223-1 Manufacturer Authorized representative in the ISO 15223-1 European Community ISO 15223-1 Serial number Symbol for the marking of electrical and electronics devices according to Directive 2012/19/EU.

  • Page 73: Appendix B Guidance And Manufacturer's Declaration

    To provide reasonable protection, this product complies with emissions limits for a Group 1, Class A ISM equipment Medical Devices Directive as stated in EN 60601-1-2. 【Warning 1】: The use of accessories, sensors, and/ or cables not supplied by SIUI may lead to increase of electromagnetic radiation or decrease of electromagnetic immunity, consequently resulting in operation failure.
  • Page 74 Description of EMC Guidance and manufacturer’s declaration – electromagnetic emission Emission test Compliance Mains terminal disturbance voltage Group 1 RF emissions CISPR 11 Radiated disturbance Class A RF emission CISPR 11 Harmonic emissions Complies IEC 61000-3-2 Voltage fluctuations/ flicker emissions Complies IEC 61000-3-3 Guidance and manufacturer’s declaration –...
  • Page 75 Description of EMC Guidance and manufacturer’s declaration – electromagnetic immunity Immunity test IEC 60601 test level ± 8 kV contact Electrostatic ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air discharge (ESD) IEC 61000-4-2 Radiated RF 3 V/m electromagnetic 80 MHz –...

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