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Safety Requirements
■■
Classications:
■X
Type of protection against electrical shock: Class I
■X
Degree of protection against electrical shock (Patient connection): Type BF applied part
■X
Degree of protection against harmful ingress of water: Ordinary equipment
■X
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.
■X
Mode of operation: Continuous operation
■■
Electromechanical safety standards met:
■X
Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential
Performance [IEC 60601-1: 2005]
■X
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]
■X
Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Usability [IEC 60601-1-6: 2010]
■X
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]
■X
Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1: 1988 with
A1: 1991 and A2: 1995]
■X
Medical Electrical Equipment, Part 1-1: General Requirements for Safety - Collateral Standard:
safety Requirement for Medical Electrical Systems [IEC 60601-1-1: 2000]
■X
Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2: 2001, A1: 2004]
■X
Medical Electrical Equipment, Part 1-4: General Requirements for Safety - Collateral Standard:
Programmable Electrical Medical Systems [IEC 60601-1-4: 1996, A1: 1999]
- Volume 1 1
- 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
- Table of Contents 15
- Chapter 1 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
- 2D-mode Controls 41
- Color and Power Controls 42
- M-mode and Doppler Controls 42
- Sample Volume Depth 43
- Application 43
- Related Guidance Documents 44
- - (0.23 alf) 45
- -(0.069 lf) 45
- Systematic Uncertainties 47
- Environmental Protection 49
- Introduction 51
- Specications 53
- Product Conguration 55
- Adjusting Brightness 56
- Control Panel 57
- Chapter 2 Introduction 59
- Keyboards 60
- Adjusting Control Panel 61
- Rear Panel 63
- Power Connection Part 64
- Peripheral Devices 65
- N N 66
- Connecting probes 67
- Accessory 68
- Starting Diagnosis 69
- Power Supply 71
- Probes & Applications 72
- Probe Setting Change 73
- Editing BodyMarker 74
- Add BodyMarkers 75
- Delete BodyMarkers 75
- Back to default BodyMarker 75
- Delete all BodyMarkers 75
- Save BodyMarkers 75
- Calc Sequence 76
- Patient Information 77
- Registering a New Patient 78
- [Figure 3.5 Search] 81
- Modifying Patient Information 83
- Diagnosis Modes 85
- Information 87
- Basic Use 88
- Frequency 89
- Harmonic 90
- Basic Modes 91
- Starting 2D Mode 92
- 2D Mode Menu 92
- Trapezoid 94
- 2D Mode Softmenu 96
- Entering and Exiting M Mode 97
- M Mode Screen 98
- M Mode Menu 98
- M Mode Softmenu 99
- Color Doppler Mode 100
- C Mode Screen 101
- C Mode Menu 101
- Operation Manual 102
- C Mode Softmenu 103
- Power Doppler Mode 104
- PD Mode Softmenu 105
- PD Mode Menu 105
- PW Spectral Doppler Mode 106
- Sample Volume 107
- Chapter 4 Diagnosis Modes 109
- Baseline 110
- Combined Modes 111
- Changing Menu 112
- Dual Mode 113
- 3D Mode 114
- Acquiring a 3D Image 115
- Viewing a 3D Image 116
- 3D Image Optimization 117
- Position 118
- Magnication 119
- Cut Mode 119
- Multi planar 120
- Reference Plane 120
- Measurements And 123
- Calculations 123
- Measurement Accuracy 125
- Ultrasound Velocity 126
- Doppler Signal Adjustment 126
- Aliasing 126
- Calculation Equation 126
- Human Error 126
- 2D Mode 127
- Doppler Mode 127
- Measurement Accuracy Table 128
- PW Spectral Doppler Mode 129
- Basic Measurements 130
- Distance Measurement 131
- 2D Distance (Trace) 132
- 2D Hip Joint 133
- M Distance 134
- Doppler Velocity 134
- Doppler Velocity (A/B) 135
- Doppler Trace 135
- 2D Ellipse 136
- Area = , (a, b: Axis) 137
- 22D Trace 137
- Volume Measurement 138
- Distance + Ellipse 139
- Things to note 140
- Softmenu 141
- Common Measurement Methods 142
- Limited Trace 143
- Manual Trace 143
- Volume Flow Measurement 144
- Stenosis Measurement 145
- OB Calculations 146
- Measurement Menu 147
- Automatic Calculation 150
- AFI (Amniotic Fluid Index) 150
- GYN Calculations 151
- Cardiac Calculations 153
- Vascular Calculations 158
- Urology Calculations 161
- 3 Distance 162
- 3 Distance * Factor 163
- Ellipsoid 163
- Sum of 20 Disks 165
- Fetal Echo Calculations 166
- Report 169
- Viewing Report 170
- Editing Report 170
- Comment 170
- Printing out Report 170
- Exporting Report 170
- Graph Function 171
- Viewing Graph 172
- Viewing History 172
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