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Safety Requirements
■
Classication:
▶
Type of protection against electrical shock: Class I
▶
Degree of protection against electrical shock (Patient connection): Type BF applied part
▶
Degree of protection against harmful ingress of water: Ordinary equipment
▶
Degree of safety of application in the presence of a ammable anesthetic material with air or with
oxygen or nitrous oxide: Equipment not suitable for use in the presence of a ammable anesthetic
mixture with air or with oxygen or nitrous oxide.
▶
Mode of operation: Continuous operation
■
Electromechanical safety standards met:
▶
Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential
Performance
[IEC 60601-1:2005]
▶
Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
[IEC
60601-1-2:2007]
▶
Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Usability
[IEC 60601-1-6:2010]
▶
Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential
Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
[IEC 60601-2-37:2007]
▶
Medical Electrical Equipment, Part 1: General Requirements for Safety
[IEC 60601-1:1988 with
A1:1991 and A2:1995]
▶
Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standard: safety
Requirement for Medical Electrical Systems
[IEC 60601-1-1:2000]
▶
Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Test
[IEC 60601-1-2:2001, A1:2004]
▶
Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems
[IEC 60601-1-4:1996, A1:1999]
▶
Medical Electrical Equipment, Part 2-37: Particular Requirements for Safety - Ultrasonic Medical
Diagnostic and Monitoring Equipment
[IEC 60601-2-37: 2001 with A1:2004, A2:2005]
▶
Medical Devices – Application of Risk Management to Medical Devices
[ISO 14971:2007]
- Volume 1 1
- WARRANTY 5
- Safety Requirements 8
- Declarations: 9
- READ THIS FIRST 10
- If You Need Assistance 11
- Revision History 12
- Table of Contents – Volume 1 13
- Chapter3 Starting Diagnosis 14
- Chapter4 Diagnosis Modes 14
- ** Reference Manual 15
- Chapter1 17
- Indication for Use 19
- Safety Signs 20
- Chapter 1 Safety 21
- Electrical Safety 24
- Mechanical Safety 33
- Safety Note 34
- Biological Safety 35
- Applying ALARA 36
- Direct Controls 36
- Indirect Controls 37
- Receiver Controls 37
- Additional Considerations 38
- Output Display Features 38
- Mechanical Index (MI) Display 39
- Thermal Index (TI) Display 39
- Control aecting the indices 40
- Color and Power Controls 41
- 2D-mode Controls 41
- M-mode and Doppler Controls 42
- Related Guidance Documents 43
- -(0.23 alf) 44
- -(0.069 lf) 45
- Systematic Uncertainties 46
- Environmental Protection 48
- Introduction 49
- Specications 51
- Product Conguration 53
- Adjusting Brightness 54
- Control Panel 55
- Chapter 2 Introduction 57
- Keyboards 58
- Adjusting Control Panel 59
- Rear Panel 61
- Power Connection Part 62
- Probe Holder 62
- Peripheral Devices 63
- USB to RS-232C Serial Cable 64
- Foot Switch 64
- Connecting probes 65
- Accessory 66
- Starting Diagnosis 69
- Power Supply 71
- Probes & Applications 72
- Probe Setting Change 73
- Calc Sequence 74
- Patient Information 75
- Registering a New Patient 76
- [Figure 3.4 Search] 79
- Modifying Patient Information 82
- Diagnosis Modes 83
- Information 85
- Basic Use 86
- QuickScan 87
- Frequency 88
- Harmonic 88
- Basic Modes 89
- 2D Mode Menu 90
- 2D Mode Softmenu 94
- Entering and Exiting M Mode 95
- M Mode Screen 95
- M Mode Menu 96
- M Mode Soft Menu 96
- Color Doppler Mode 97
- C Mode Menu 98
- C Mode Softmenu 100
- Power Doppler Mode 101
- PD Mode Menu 102
- PD Mode Soft Menu 102
- PW Spectral Doppler Mode 103
- Sample Volume 104
- PW Spectral Doppler Mode Menu 105
- Spectrum Ehc 106
- Simultaneous 106
- PW Size 106
- Baseline 107
- Combined Modes 108
- Changing Combined Mode Format 109
- Dual Mode 110
- Chapter 4 Diagnosis Modes 111
- Acquiring a 3D Image 112
- Viewing a 3D Image 113
- 3D Image Optimization 114
- Position 115
- Magnication 116
- Cut Mode 116
- Multi planar 117
- Reference Plane 117
- Operation Manual 118
- Measurements and 119
- Calculations 119
- Measurement Accuracy 121
- Ultrasound Velocity 122
- Doppler Signal Adjustment 122
- Aliasing 122
- Calculation Equation 122
- Human Error 122
- Doppler Mode 123
- Color/Power Doppler Mode 124
- Cursor Position 124
- Measurement Accuracy Table 125
- Basic Measurements 127
- Basic Measurement Operations 128
- Distance Measurement 129
- 2D Hip Joint 130
- M Distance 131
- Doppler Velocity 131
- Doppler Velocity (A/B) 132
- Doppler Trace 133
- 2D Ellipse 134
- 2D Trace 135
- Volume Measurement 136
- Distance + Ellipse 137
- Calculations by Application 138
- Measurement Operations 139
- Soft Menu 140
- Common Measurement Methods 141
- Volume Flow Measurement 143
- Stenosis Measurement 143
- Heart Rate Measurement 144
- OB Calculations 145
- AFI (Amniotic Fluid Index) 147
- GYN Calculations 148
- Cardiac Calculations 150
- Vascular Calculations 156
- Measurement Menu 157
- Mode Method Unit 157
- Urology Calculations 158
- 3 Distance * Factor 159
- Ellipsoid 160
- Sum of 20 Disks 161
- Fetal Echo Calculations 162
- Viewing Report 166
- Editing Report 166
- Comment 166
- Printing out Report 166
- Exporting Report 167
- Graph Function 168
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