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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]
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Medical Devices - Application of Risk Management to Medical Devices [ISO 14971:2007]
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Medical Electrical Equipment, Part 1: General Requirements for Safety [UL 60601-1:2003]
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Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA C22.2
No.601.1-M90:1990, with R2003, with R2005]
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Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a risk management
process [ISO 10993-1:2009]
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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
- Chapter3 Starting Diagnosis 14
- Chapter4 Diagnosis Modes 14
- ** Reference Manual 16
- Chapter1 17
- Indication for Use 19
- Safety Signs 20
- Chapter 1 Safety 21
- Electrical Safety 24
- ECG-Related Information 26
- Mechanical Safety 34
- Safety Note 35
- Biological Safety 36
- Applying ALARA 37
- Direct Controls 37
- Indirect Controls 38
- Additional Considerations 39
- Output Display Features 39
- Mechanical Index (MI) Display 40
- Thermal Index (TI) Display 40
- 2D-mode Controls 42
- Color and Power Controls 42
- Related Guidance Documents 44
- - (0,23 alf) 45
- - (0,069 lf) 46
- Systematic Uncertainties 47
- Training 48
- Environmental Protection 49
- Introduction 51
- Specications 53
- Chapter 2 Introduction 55
- Monitor 59
- Image Area 60
- Thumbnails Area 60
- User Information Area 60
- Soft Menu 60
- Control Panel 61
- Keyboard 64
- Adjusting Control Panel 65
- Rear Panel 66
- Power Connection Part 67
- Probe Holder 67
- N N 68
- Video Cassette Recorder (VCR) 69
- Video Page printer 69
- USB Video Printer 69
- USB to RS-232C Serial Cable 70
- USB Foot Switch 70
- POWER CORD 72
- Optional Functions 73
- Starting Diagnosis 75
- Power Supply 77
- Probes & Applications 78
- Changing Application 79
- Editing Probe Preset Values 79
- Patient Information 81
- Accession 82
- General 83
- Sonographer 84
- Description 84
- Indication 84
- LMP (Last Menstrual Period) 85
- GA (LMP) 85
- EDD (LMP) 85
- Estab. Due Date 85
- Gynecology 87
- Cardiac 87
- Urology 88
- Finding Patient Information 89
- Worklist Search 90
- Managing Patient Exams 91
- Viewing Exam 92
- Deleting Exam 92
- Sending Exams via DICOM 93
- Printing Exams via DICOM 94
- Exporting Exam 94
- [Figure 3.13 Image Export] 95
- Backing up Exam 96
- Changing Measurements 97
- The View Screen 98
- Diagnosis Modes 101
- Chapter 4 102
- Information 103
- Basic Use 104
- Using Soft Menu 105
- Basic Mode 106
- 2D Mode Soft Menu 107
- FSI / M Line 108
- Read Zoom / Write Zoom 108
- Chapter 4 Diagnosis Modes 109
- Gray Map / L/R Flip 110
- Focus / U/D Flip 110
- Sector Width 110
- Frame Avg 110
- 2D Image Size 111
- Edge Enhance 111
- Pulse Inversion 111
- Frame Rate 112
- DynamicMR (Optional) 112
- Panoramic 113
- Operation Manual 114
- M Mode Screen 116
- M Mode Soft Menu 116
- Color Doppler Mode 117
- C Mode Screen 118
- C Mode Soft Menu 118
- Power Doppler Mode 120
- PD Mode Screen 121
- PD Mode Soft Menu 121
- PW Spectral Doppler Mode 122
- Sample Volume 123
- HPRF (High PRF) Function 123
- SV Size / Angle 124
- Auto Calc 124
- AutoCalc Direction 125
- Simultaneous 125
- Mean Trace 126
- Baseline 126
- CW Spectral Doppler Mode 127
- TDI Mode 128
- TDW Mode 129
- ElastoScan Mode 130
- E Single Mode 131
- ROI Mode 132
- Performing a Scan 133
- Screen Layout 134
- E Mode Menu 135
- Cine/Measurement 136
- Cine Edit 136
- Cine Review 136
- Cine Save 136
- Combined Mode 137
- 2D/C/M Mode 138
- 2D/C Live Mode 138
- Multi-Image Mode 139
- Quad Mode 140
- 3D/4D Mode 141
- 3D/4D Mode Screen 142
- 3D StandBy Mode 143
- View Mode 144
- Load Preset 144
- Scan Quality / Auto ROI 144
- Acquiring 3D Images 145
- 3D View-MPR 147
- Trackball Mode 148
- Moving Images 148
- Saving and Printing 150
- MPR Mode Menu 151
- Display 151
- Fixed 3D 152
- Cine Type 156
- Render Setup 158
- § Gray Render Mode 158
- Render Mode 2 159
- TH. High 159
- 2D Palette 160
- 3D Palette 160
- MPR Mode Soft Menu 161
- 3D XI Mode (Optional) 163
- MSV Mode Menu 164
- Post Processing 165
- MSV Mode Soft Menu 166
- Oblique View 167
- Oblique View Mode Menu 169
- Oblique View Mode Soft Menu 170
- Volume CT Mode 171
- Cube Volume CT 172
- Cross Volume CT 173
- Measurements and 175
- Calculations 175
- Chapter 5 176
- Measurement Accuracy 177
- Doppler Signal Adjustment 178
- Aliasing 178
- Calculation Equation 178
- Human Error 178
- 2D Mode 179
- M Mode 179
- Doppler Mode 179
- Color/Power Doppler Mode 180
- Cursor Position 180
- Measurement Accuracy Table 181
- Basic Measurements 183
- Cancel Measurement Results 184
- Delete Measurement Result 184
- Print Measurement Result 184
- Finish Basic Measurements 184
- Distance Measurement 185
- Angle 186
- M Distance 186
- D Velocity 187
- D A/B 188
- D Trace 189
- Ellipse 190
- Trace 191
- Volume Measurement 192
- Distance + Ellipse 193
- Calculations by Application 195
- Measurement 196
- Font Size 198
- Common Measurement Methods 199
- Limited Trace 201
- Manual Trace 201
- Itemized Measurement 201
- Volume Flow Measurement 203
- Stenosis Measurement 203
- Heart Rate Measurement 204
- OB Calculation 205
- Measurement Menu 206
- Automatic Calculation 214
- AFI (Amniotic Fluid Index) 215
- How to measure 216
- Gynecology Calculation 218
- Cardiac Calculation 225
- Carotid Calculation 237
- Auto IMT Screen 244
- Measure Result Table 245
- Auto IMT Measurement 246
- Annotation 248
- Auto IMT+ 248
- Urology Calculation 249
- 3Distance 250
- 3 Distance * Factor 252
- Ellipsoid 252
- Sum of 20 Disks 253
- Fetal Echo Calculation 254
- LE Artery Calculation 259
- UE Artery Calculation 269
- LE Vein Calculation 274
- UE Vein Calculation 278
- Radiology Calculation 283
- TCD Calculation 291
- Thyroid Calculation 297
- Breast Calculation 299
- Testicle Calculation 301
- Supercial Calculation 303
- Pediatric Hips Calculation 305
- Musculoskeletal Calculation 307
- Viewing Report 309
- Video Out 310
- Editing Report 310
- Modify Measurements 311
- Measurement Display Method 311
- Fetal Description 311
- Adding Comment 312
- Printing Report 313
- Saving Report 313
- Transferring Report 314
- Stress Echo Report 314
- Graph Function 315
- History 317
- Closing Report 319
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