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Medical Electrical Equipment, Part 1: General Requirements for Safety
[UL 60601-1:2003]
▶
Medical Electrical Equipment - Part 1: General Requirements for Safety
[CAN/CSA C22.2 No. 601.1-
M90:1990, with R2003, with R2005]
▶
Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management
process
[ISO 10993-1 : 2009]
▶
Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
[IEC 61157:2007]
■
Declarations:
This is CSA symbol for Canada and United States of America
This is manufacturer’s declaration of product compliance with
applicable EEC directive(s) and the European notied body.
This is manufacturer’s declaration of product compliance with
applicable EEC directive(s).
- 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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