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Safety Requirements
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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
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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]
- 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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