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๎X 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]
๎X Medical Devices โ Application of Risk Management to Medical Devices [ISO 14971: 2007]
๎X Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-1: 2003]
๎X Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA C22.2 No. 601.1-
M90: 1990, with R2003, with R2005]
๎X Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management
process [ISO 10993-1: 2009]
๎X Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment [IEC 61157: 2007]
๎๎
Declarations
This is the CSA symbol for Canada and United States of America.
This is the manufacturerโs declaration of product compliance with applicable EEC
directive(s) and the European notified body.
This is the manufacturerโs declaration of product compliance with applicable EEC
directive(s).
This is the GMP symbol that shows that the product complies with the Korean Good
Manufacturing Practice quality regulation system.
- Safety Requirements 8
- Declarations 9
- Precautions For Use 10
- Revision History 11
- Table of Contents 13
- Chapter 3 Starting Diagnosis 14
- Chapter 4 Diagnosis Modes 14
- Chapter 6 Image Management 15
- Chapter 7 Utilities 16
- Chapter 8 Maintenance 16
- Chapter 9 Probes 17
- Chapter 1 19
- Indication for Use 21
- Safety Information 22
- Chapter 1 Safety 23
- Electrical Safety 26
- ECG-Related Information 28
- Peripheral Devices 30
- Mechanical Safety 36
- Moving the Equipment 37
- Biological Safety 38
- ๎ Applying ALARA 39
- ๎ Direct Controls 39
- ๎ Indirect Controls 40
- ๎ Additional Considerations 41
- ๎ Output Display Features 41
- Mechanical Index (MI) Display 42
- Thermal Index (TI) Display 42
- ๎ 2D Mode Controls 44
- ๎ Color and Power Controls 44
- Color Sector Depth 45
- 2D Mode Size 45
- Sample Volume Depth 45
- ๎ Other 46
- ๎ Related Guidance Documents 46
- - (0,23 alf) 48
- -(0,069 lf) 48
- Systematic Uncertainties 51
- ๎ Training 52
- Protecting the Environment 53
- Battery Pack 54
- Introduction 57
- Product Speci๎cations 59
- Product Con๎guration 61
- ๎ Touch Screen 62
- Chapter 2 Introduction 63
- ๎ Touch Panel 64
- Console 65
- ๎ Console โ Left Side 66
- ๎ Console โ Right Side 66
- ๎ Console - Top 66
- ๎ Console - Bottom 66
- USB Video Printer 68
- Foot Switch 68
- Video Out 69
- Battery Pack 71
- ๎ Battery Icons 72
- ๎ Connecting Probes 73
- UGEO PT60A CART (Optional) 74
- Accessories 75
- Optional Functions 77
- Starting Diagnosis 79
- System Power 81
- Turning the Power On 82
- Shutting Down the System 82
- Probes and Applications 83
- Patient Information 84
- ๎ Gynecology 88
- ๎ Urology 88
- ๎ Vascular 88
- ๎ Abdomen 89
- ๎ Pediatric 89
- ๎ Anesthesia 91
- ๎ Emergency 91
- Searching Patient Information 92
- ๎ Worklist Search 93
- Diagnosis Modes 95
- Information 97
- Basic Operating Instructions 98
- Basic Mode 100
- ๎ Entering 2D Mode 101
- ๎ 2D Mode Menu 101
- Freq.(Frequency) 102
- Frame Average 102
- DR (Dynamic Range) 102
- Line Density 102
- Spatial Compound 103
- ROI Control 103
- Biopsy Guide 104
- Needle Mate 105
- ๎ M Mode Screen 106
- ๎ M Mode Menu 107
- Color Doppler Mode 108
- ๎ C Mode Menu 109
- Baseline 110
- Power Doppler Mode 111
- ๎ PD Mode Menu 112
- PW Spectral Doppler Mode 113
- Adjusting Doppler Baseline 114
- Simul. (Simultaneous) 114
- Wall Filter 115
- Combined Mode 116
- Measurements and 117
- Calculations 117
- Measurement Accuracy 119
- ๎ Ultrasound Velocity 120
- ๎ Doppler Signal Adjustment 120
- ๎ Aliasing 120
- ๎ Calculation Equation 120
- ๎ Human Error 120
- ๎ 2D Mode 121
- ๎ M Mode 121
- ๎ Doppler Mode 121
- ๎ Color/Power Doppler Mode 122
- ๎ Cursor Position 122
- Measurement Accuracy Table 123
- Basic Measurements 124
- Deleting Measurement Results 125
- Printing Measurement Results 125
- Exiting Basic Measurement 125
- Distance measurement 126
- ๎ Angle 127
- ๎ Distance (M) 128
- ๎ Time (M) 128
- ๎ Slope 128
- ๎ Velocity 129
- ๎ Manual Trace 129
- Duration of flow 130
- ๎ Ellipse 132
- ๎ Trace 133
- Volume measurement 134
- Calculations by Application 135
- Operation Manual 136
- Common Measurement Methods 137
- ๎ Heart Rate Measurement 138
- OB Calculations 139
- ๎ Automatic Calculation 140
- ๎ AFI(Amniotic Fluid Index) 140
- Gynecology Calculations 142
- Vascular Calculations 144
- [Figure 5.2 Auto IMT] 145
- Viewing Reports 147
- ๎ Measurement Display Method 148
- Adding Comments 149
- Store SR 149
- Printing Reports 150
- Closing Reports 150
- Image Management 151
- Cine / Loop 153
- ๎ How to Review Images 154
- ๎ Cine Play 154
- ๎ Cine Speed 154
- Annotating Images 155
- ๎ Entering Text 156
- ๎ Text Library Menu 156
- ๎ Deleting Text 157
- ๎ Arrow Mode 157
- ๎ Entering Arrow 158
- ๎ Deleting Arrows 158
- BodyMarker 159
- Exiting Annotation 160
- Saving Images 161
- Transferring Images 162
- SonoView Mode 163
- ๎ Launching SonoView Mode 164
- Exam Mode 165
- ๎ Searching for an Exam 166
- ๎ Selecting Image 166
- ๎ Thumb Scroll 166
- ๎ Layouts 166
- ๎ Clip Play/Pause/Stop 166
- ๎ Transferring Images 167
- ๎ Print 167
- ๎ Deleting Images 168
- ๎ Exiting SonoView 168
- Utilities 169
- System Settings 171
- General System Settings 172
- ๎ Date and Time 173
- ๎ Screen Saver 173
- ๎ Common Settings 174
- Annotation Settings 175
- Measurement Settings 176
- ๎ Heart Rate 177
- ๎ Author Settings 177
- ๎ EFW Settings 178
- Peripheral Device Settings 179
- ๎ Store 180
- ๎ Brightness 180
- Network Settings 181
- DICOM Settings 182
- ๎ DICOM Service Settings 183
- Worklist Service Server 184
- Storage Server Information 185
- Print Server Information 185
- SC Server Information 185
- PPS Server Information 185
- Storage SR Server Information 186
- Maintenance 189
- Operational Environment 191
- Product Maintenance 192
- Accuracy Checks 193
- Battery Pack Management 194
- Recharging the Battery Pack 195
- Storing the Battery Pack 197
- Disposing of the Battery Pack 197
- Information Maintenance 198
- Chapter 9 199
- ๎ Probe List 201
- Function List 203
- ๎ Thermal Index (TI) Tables 204
- Using Ultrasound Gel 205
- Using Sheaths 206
- Probe Safety Precautions 207
- ๎ Electric Shocks 208
- ๎ Cleaning 215
- ๎ Disinfection 216
- Biopsy Kit Components 217
- Using the Biopsy Kit 218
- ๎ Biopsy Procedure 219
- ๎ Needle Guide Alignment 220
- Cleaning 221
- Disinfection 221
- Sterilization 222
- Assembling the Biopsy Kit 223
- ๎ C2-8 Biopsy Guide 225
- ๎ LN5-12 Biopsy Guide 227
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