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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]
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
- Safety Requirements 8
- Declarations: 9
- READ THIS FIRST 10
- If You Need Assistance 11
- Revision History 12
- Table of Contents – Volume 1 13
- ** Reference Manual 15
- Chapter1 17
- Indication for Use 19
- Safety Signs 20
- Chapter 1 Safety 21
- Electrical Safety 23
- Mechanical Safety 33
- Biological Safety 34
- Applying ALARA 35
- Direct Controls 35
- Indirect Controls 36
- Receiver Controls 36
- Additional Considerations 37
- Output Display Features 37
- Mechanical Index (MI) Display 38
- Thermal Index (TI) Display 38
- Control aecting the indices 39
- Color and Power Controls 40
- 2D-mode Controls 40
- M-mode and Doppler Controls 41
- Related Guidance Documents 42
- -(0.23 alf) 43
- -(0.069 lf) 44
- Systematic Uncertainties 45
- Training 46
- Environmental Protection 47
- Introduction 49
- Specications 51
- Product Conguration 53
- Adjusting Brightness 54
- Control Panel 55
- Control Panel Map 56
- Chapter 2 Introduction 57
- Keyboards 58
- Measurement function keys 59
- Rear Panel 61
- Power Connection Part 62
- Probe Holder 62
- 1.5m 1.5m 63
- Inkjet Printer 64
- USB to RS-232C Serial Cable 64
- Foot Switch 64
- Connecting probes 65
- SONOACE R3 Cart (Optional) 66
- Accessory 67
- Starting Diagnosis 69
- Power Supply 71
- Probes & Applications 72
- Application 73
- Editing BodyMarker 74
- Back to default BodyMarker 75
- Delete all BodyMarkers 75
- Save BodyMarkers 75
- Calc Sequence 76
- Patient Information 77
- Registering a New Patient 78
- Calculating EDD 79
- [Figure 3.5 Search] 81
- Modifying Patient Information 84
- Diagnosis Modes 85
- Information 87
- Basic Use 88
- QuickScan 89
- Frequency 89
- Harmonic 90
- Basic Modes 91
- 2D Mode Menu 92
- 2D Mode Softmenu 96
- Entering and Exiting M Mode 97
- M Mode Screen 97
- M Mode Menu 98
- M Mode Soft Menu 98
- Color Doppler Mode 99
- C Mode Menu 100
- Chapter 4 Diagnosis Modes 101
- C Mode Softmenu 102
- Power Doppler Mode 103
- PD Mode Menu 104
- PD Mode Soft Menu 104
- PW Spectral Doppler Mode 105
- Sample Volume 106
- PW Spectral Doppler Mode Menu 107
- Spectrum Ehc 108
- Simultaneous 108
- PW Size 108
- Baseline 109
- Combined Modes 110
- Changing Combined Mode Format 111
- Dual Mode 112
- Acquiring a 3D Image 114
- Viewing a 3D Image 115
- 3D Image Optimization 116
- Position 117
- Magnication 118
- Cut Mode 118
- Multi planar 119
- Reference Plane 119
- Operation Manual 120
- Measurements and 121
- Calculations 121
- Chapter 5 122
- Measurement Accuracy 123
- Doppler Signal Adjustment 124
- Aliasing 124
- Calculation Equation 124
- Human Error 124
- Doppler Mode 125
- Color/Power Doppler Mode 126
- Cursor Position 126
- Measurement Accuracy Table 127
- Basic Measurements 129
- Basic Measurement Operations 130
- Distance Measurement 131
- 2D Hip Joint 132
- M Distance 132
- Doppler Velocity 133
- Doppler Velocity (A/B) 133
- Doppler Trace 134
- 2D Ellipse 135
- 2D Trace 136
- Volume Measurement 137
- Distance + Ellipse 138
- Calculations by Application 139
- Soft Menu 140
- Change Method 141
- Cancel / Undo 141
- Rslt Disp Cnt 141
- Common Measurement Methods 142
- Volume Flow Measurement 143
- Stenosis Measurement 144
- Heart Rate Measurement 144
- OB Calculations 145
- Automatic Calculation 148
- AFI (Amniotic Fluid Index) 148
- GYN Calculations 150
- Cardiac Calculations 152
- Vascular Calculations 158
- Urology Calculations 160
- 3 Distance * Factor 161
- Ellipsoid 161
- Sum of 20 Disks 163
- Fetal Echo Calculations 164
- Viewing Report 167
- Editing Report 167
- Comment 167
- Printing out Report 167
- Exporting Report 167
- Open Line Transfer 168
- Graph Function 169
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