SIUI SR-8210 Bedienungsanleitung

SSNCXALV110ENA

SR-8210

Portable X-Ray Unit

OPERATION MANUAL

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

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: 86-754-88250150 Fax: 86-754-88603664

E-mail: siui@siui.com or service@siui.com

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

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

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