ESAOTE_B超mylabfive_操作技术手册01.pdfVIP

ESAOTE Rev. A March 2007 SAFETY AND STANDARDS OPERATOR MANUAL Doc # 29B05EN01 Introduction This manual provides information on Safety and Standards for the MyLab product line. This manual is organized in the following chapters: • Chapter 1: Operator Safety This chapter describes the situations that could affect the operator safety when an ultrasound system is used. • Chapter 2: Patient Safety This chapter describes the situations that could affect the patient safety when an ultrasound system is used. • Chapter 3: Standards This chapter lists with which standards MyLab complies. It also lists with which standards the peripherals connected to the device have to comply. In this manual a WARNING pertains to possible injury to a patient and/or the operator. A CAUTION describes the precautions, which are necessary to protect the equipment. Be sure that you understand and observe each of the cautions and warnings. Table of Contents 1 - Operator Safety1-1 Installation Requirements 1-1 Electrical Safety1-1 Environmental Safety1-2 Moving the Equipment 1-2 Explosive Hazard1-3 Transducers1-3 Biocompatibility and Infection Control1-4 Repetitive Strain Injury1-4 Working with Video Display1-5 Safety Symbols 1-5 2 - Patient Safety2-1 Electrical Safety2-1 Electromagnetic Compatibility 2-2 Biocompatibility and Infection Control2-2 Ultrasound Safety 2-3 Glossary and Definition of Terms2-12 3 - Devices Standards 3-1 Medical Device Directive 3-1 Medical Electrical Equipment Standard 3-1 Electromagnetic Compatibility 3-1 Biocompatibility 3-1 Standards Summary Table 3-2 Acoustic Output 3-2 Peripherals Sta