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Safety Requirements
■
Classication:
Type of protection against electrical shock: Class I
Degree of protection against electrical shock (Patient connection): Type BF equipment
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
■
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 60601-1-6:2006]
Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and Essential
Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC60601-2-37:2007]
Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with
A1:1991 and A2:1995]
Medical Electrical Equipment, Part 1: General Requirements for Safety – 1 Collateral Standard: safety
Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]
Medical Electrical Equipment, Part 1: General Requirements for Safety - 2 Collateral Standard:
Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001, A1:2004]
- WARRANTY 3
- Safety Requirements 8
- Declarations: 9
- READ THIS FIRST 10
- If You Need Assistance 11
- Revision History 12
- Contents 13
- ** Reference Manual 17
- Chapter1 19
- Indication for Use 21
- Safety Signs 22
- Chapter 1 Safety 23
- [Label 1. ID label] 24
- 275-K-A826B 24
- Electrical Safety 25
- Mechanical Safety 35
- Biological Safety 36
- Applying ALARA 37
- Direct Controls 37
- Indirect Controls 38
- Receiver Controls 38
- Additional Considerations 39
- Output Display Features 39
- Mechanical Index (MI) Display 40
- Thermal Index (TI) Display 40
- Control aecting the indices 41
- 2D-mode Controls 42
- Color and Power Controls 42
- M-mode and Doppler Controls 43
- Related Guidance Documents 44
- -(0.23 alf) 45
- -(0.069 lf) 46
- Systematic Uncertainties 47
- Training 48
- Environmental Protection 49
- Introduction 51
- Specications 53
- Product Conguration 55
- Adjusting Brightness 56
- Control Panel 57
- Control Panel Map 58
- Chapter 2 Introduction 59
- [Figure 2.4 keyboards] 60
- Measurement function keys 61
- [Figure 2.5 Console] 62
- [Figure 2.6 Rear Panel] 63
- Power Connection Part 64
- Probe Holder 64
- Peripheral Devices 65
- 1.5m 1.5m 65
- Inkjet Printer 66
- USB to RS-232C Serial Cable 66
- Foot Switch 66
- [Figure 2.9 Probe Connector] 67
- SONOACE R3 Cart (Optional) 68
- [Figure 2.10 SONOACE R3 Cart] 68
- Accessory 69
- Starting Diagnosis 71
- Power Supply 73
- Probes & Applications 74
- Application 75
- Probe Setting Change 75
- Editing Bodymarker 76
- Back to default Bodymarker 77
- Delete all Bodymarkers 77
- Save Bodymarkers 77
- Calc Sequence 78
- Patient Information 79
- Registering a New Patient 80
- Calculating EDD 81
- [Figure 3.5 Search] 83
- Modifying Patient Information 86
- Diagnosis Modes 87
- Basic Use 90
- QuickScan 91
- Frequency 91
- Harmonic 92
- Basic Modes 93
- 2D Mode Menu 94
- [Figure 4.2 2D Post] 96
- [Figure 4.3 2D Post Edit] 97
- 2D Mode Softmenu 98
- [Figure 4.4 M Mode] 99
- M Mode Menu 100
- M Mode Soft Menu 100
- Color Doppler Mode 101
- C Mode Menu 102
- Chapter 4 Diagnosis Modes 103
- C Mode Softmenu 104
- Power Doppler Mode 105
- PD Mode Soft Menu 106
- PD Mode Menu 106
- PW Spectral Doppler Mode 107
- Sample Volume 108
- [Figure 4.8 HPRF] 109
- Spectrum Ehc 110
- Simultaneous 110
- PW Size 110
- Baseline 111
- Combined Modes 112
- Changing Combined Mode Format 113
- Dual Mode 114
- Acquiring a 3D Image 116
- [Figure 4.9 3D View] 117
- 3D Image Optimization 118
- Position 119
- Magnication 120
- Cut Mode 120
- [Figure 4.16 Multi planar] 121
- Operation Manual 122
- Measurements and 123
- Calculations 123
- Chapter 5 124
- Measurement Accuracy 125
- Doppler Signal Adjustment 126
- Aliasing 126
- Calculation Equation 126
- Human Error 126
- Doppler Mode 127
- Color/Power Doppler Mode 128
- Cursor Position 128
- Measurement Accuracy Table 129
- Basic Measurements 131
- Basic Measurement Operations 132
- Distance Measurement 133
- 2D Hip Joint 134
- M Distance 134
- Doppler Velocity 135
- Doppler Velocity (A/B) 135
- Doppler Trace 136
- 2D Ellipse 137
- 2D Trace 138
- Volume Measurement 139
- Distance + Ellipse 140
- Calculations by Application 141
- Soft Menu 142
- Change Method 143
- Cancel / Undo 143
- Rslt Disp Cnt 143
- Common Measurement Methods 144
- Volume Flow Measurement 145
- Stenosis Measurement 146
- Heart Rate Measurement 146
- OB Calculations 147
- Automatic Calculation 150
- AFI (Amniotic Fluid Index) 150
- GYN Calculations 152
- Cardiac Calculations 154
- Vascular Calculations 160
- Urology Calculations 162
- 3 Distance * Factor 163
- Ellipsoid 163
- Sum of 20 Disks 165
- Fetal Echo Calculations 166
- Viewing Report 169
- Editing Report 169
- Comment 169
- Printing out Report 169
- Exporting Report 169
- Open Line Transfer 170
- Graph Function 171
- Image Management 173
- CINE / LOOP 175
- How to Review Images 176
- Cine Save 177
- Speed (%) 177
- Annotating Images 178
- Autotext 179
- Deleting Text 179
- Exiting Text Mode 179
- Body Marker 180
- [Figure 6.4 Body Marker Mode] 180
- Entering Body Marker 181
- Changing Body Marker Position 181
- Deleting Body Marker 181
- Exiting Body Marker Mode 181
- [Figure 6.5 Indicator Mode] 182
- Indicator 182
- Deleting Indicator 183
- Exiting Indicator Mode 183
- Saving Images 184
- Transferring Images 185
- Printing and Recording Images 186
- SONOVIEW 187
- Exam View 188
- [Figure 6.7 Exam View] 188
- Selecting Exam 189
- Searching Exam 189
- View Exam 189
- Deleting Exam 189
- [Figure 6.8 Exam Export] 190
- Exam Backup 191
- Exam Restore 191
- Sending Exam 192
- [Figure 6.9 DICOM Send] 193
- Exam Review 194
- [Figure 6.10 Exam Review] 194
- Close Exam 195
- Exam Search 195
- Using Preview 195
- Printing 196
- DICOM Send (Optional) 196
- DICOM Printing (Optional) 197
- Distance 198
- Closing SONOVIEW 199
- Utilities 201
- Chapter 7 202
- Setting System 203
- Language 204
- Boot up caps lock status 205
- Autotext Set 205
- Display 206
- Simultaneous Mode 207
- OB Measure Shortcut Key 208
- Shortcut Key Setup 208
- Hibernation 208
- Thumbnail 209
- Set / Exit Key Setup 209
- Trackball Speed 209
- Setting Measurements 210
- Chapter 7 Utilities 211
- Doppler 212
- [Figure 7.9 Measure - Report] 214
- [Figure 7.10 Measure – OB] 215
- [Figure 7.11 New Preset] 216
- [Figure 7.12 Graph] 217
- [Figure 7.13 Backup/Restore] 218
- Fetal Echo 219
- Cardiac 220
- Urology Measurement Setup 221
- Vascular 223
- Setting DICOM (Optional) 224
- Setting DICOM Information 225
- Network Setup 225
- Print Server Information 227
- Worklist Server Settings 229
- Scheduled Station AE Title 230
- Start Date 230
- Deleting DICOM Server 231
- Testing DICOM Server 231
- DICOM Log 231
- Setting Option 233
- Setting Peripheral Devices 234
- Printer 1 235
- Printer 2 235
- Information 236
- Utility 237
- [Figure 7.27 Biopsy Edit] 238
- Starting and Finishing Biopsy 239
- Monitor Calibration 240
- [Figure 7.29 Preset] 241
- Miscellaneous 241
- [Figure 7.30 Miscellaneous] 241
- [Figure 7.31 Histogram] 242
- Maintenance 243
- Operating Environment 245
- System Maintenance 246
- Accuracy Check 247
- Data Maintenance 248
- Chapter 8 Maintenance 249
- Chapter 9 251
- Probe List 253
- Function list 254
- Chapter 9 Probes 255
- TI Table 258
- Ultrasound transmission Gel 259
- Probe Precautions 260
- Electric Shocks 261
- Cleaning 267
- [Figure 9.1 Disinfection] 268
- Biopsy KIT Components 269
- Using the Biopsy Kit 270
- Needle Guide Alignment 271
- Cleaning 272
- Disinfection 272
- Assembling the Biopsy Kit 274
- C2-5 Biopsy Guide (Metal) 276
- C2-8 Biopsy Guide 278
- CN2-8 Biopsy Guide 280
- L5-12/60 Biopsy Guide 282
- LE5-12 Biopsy Guide 284
- LN5-12 Biopsy Guide 286
- LN5-12/40 Biopsy Guide 288
- EC4-9 Biopsy guide 290
- EVN4-9 Biopsy Guide 291
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