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Chapter 7: Safety 103
Safety
Electromagnetic compatibility
The ultrasound system has been tested and found to comply with the electromagnetic compatibility
(EMC) limits for medical devices to IEC 60601-1-2:2001. These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation.
WARNING:
The Edge ultrasound system should not be used adjacent to or stacked with other
equipment. If such use occurs, verify that the Edge ultrasound system operates
normally in that configuration.
Caution:
Medical electrical equipment requires special precautions regarding EMC and must
be installed and operated according to these instructions. Portable and mobile RF
communications equipment can affect the ultrasound system. Electromagnetic
interference (EMI) from other equipment or interference sources could result in
performance disruption of the ultrasound system. Evidence of disruption may
include image degradation or distortion, erratic readings, equipment ceasing to
operate, or other incorrect functioning. If this occurs, survey the site to determine
the source of disruption, and take the following actions to eliminate the source(s).
• Turn equipment in the vicinity off and on to isolate disruptive equipment.
• Relocate or re-orient interfering equipment.
• Increase distance between interfering equipment and your ultrasound system.
• Manage use of frequencies close to ultrasound system frequencies.
• Remove devices that are highly susceptible to EMI.
• Lower power from internal sources within facility control (such as paging
systems).
• Label devices susceptible to EMI.
• Educate clinical staff to recognize potential EMI-related problems.
• Eliminate or reduce EMI with technical solutions (such as shielding).
• Restrict use of personal communicators (cell phones, computers) in areas with
devices susceptible to EMI.
• Share relevant EMI information with others, particularly when evaluating new
equipment purchases which may generate EMI.
• Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.
Caution:
To avoid the risk of increased electromagnetic emissions or decreased immunity,
use only accessories and peripherals recommended by SonoSite. Connection of
accessories and peripherals not recommended by SonoSite to the ultrasound
system may result in malfunction of the ultrasound system or other medical
electrical devices in the area. Contact SonoSite or your local representative for a
list of accessories and peripherals available from or recommended by SonoSite.
See the SonoSite accessories user guide.
- USER GUIDE 1
- Contents 5
- Introduction 11
- Chapter 1: Getting Started 13
- To install the battery 14
- To remove the battery 14
- Turning the system on or off 15
- Connecting transducers 15
- The system does not support 16
- System controls 17
- 6 System controls 18
- Screen layout 19
- General interaction 20
- Annotation and text 21
- Preparing transducers 22
- Training videos 23
- Intended uses 24
- 14 Intended uses 26
- Chapter 2: System Setup 27
- Security settings 28
- User setup 28
- Chapter 2: System Setup 17 29
- Annotations setup 30
- Audio, Battery setup 31
- Cardiac Calculations setup 31
- Connectivity setup 31
- Date and Time setup 32
- Display Information setup 32
- IMT Calculations setup 32
- Network Status setup 32
- OB Calculations setup 32
- OB Custom Measurements 33
- OB Custom Tables setup 33
- Presets setup 34
- System Information setup 34
- USB Devices setup 34
- Limitations of JPEG format 35
- 24 USB Devices setup 36
- Chapter 3: Imaging 37
- M Mode imaging 38
- CPD and color Doppler imaging 39
- PW and CW Doppler imaging 40
- PW Doppler controls 41
- Spectral trace controls 41
- Adjusting depth and gain 42
- Freezing, viewing frames 42
- Needle visualization 43
- Needle size and angle 44
- MBe subcontrols 44
- Imaging modes and exams 45
- Annotating images 47
- Patient information form 48
- To end the exam 49
- Images and clips 50
- Reviewing patient exams 51
- ECG Monitoring 53
- 42 ECG Monitoring 54
- Chapter 4: Measurements 55
- 2D measurements 56
- M Mode measurements 57
- Doppler measurements 57
- To trace manually (Doppler) 58
- Automatic trace results 58
- General calculations 59
- EMED calculations 60
- CALCS key 61
- BACKSPACE key 61
- SET key 61
- Volume calculations 62
- Volume flow calculations 63
- To calculate volume flow 64
- Exam-based calculations 65
- 54 Exam-based calculations 66
- Measurements 67
- To measure LVd and LVs 68
- To calculate MV or AV area 69
- To calculate LV Mass 69
- To measure peak velocity 69
- 58 Exam-based calculations 70
- Index (SI) 72
- To calculate Heart Rate (HR) 72
- Cardiac Index (CI) 72
- (TDI) waveform 73
- Gynecology (Gyn) calculations 74
- IMT calculations 74
- IMT tool controls 76
- To trace IMT manually 76
- To sketch IMT 76
- OB calculations 77
- Small Parts calculations 80
- Orbital calculation 82
- Vascular calculations 83
- Patient report 84
- TCD patient report 85
- OB patient report 85
- EMED and MSK worksheets 85
- To display an MSK worksheet 86
- Measurement accuracy 87
- Sources of measurement 88
- Measurement publications 89
- Obstetrical references 93
- Gestational age tables 94
- References 95
- Growth analysis tables 96
- Ratio calculations 97
- General references 97
- Chapter 6: Troubleshooting 101
- Software licensing 102
- Maintenance 102
- Cleaning and disinfecting 103
- To clean the LCD screen 104
- Caution: 105
- Cleaning the footswitch 106
- Chapter 7: Safety 107
- Position the system 108
- Position yourself 108
- Electrical safety 109
- WARNING: 110
- Equipment safety 112
- Battery safety 112
- Clinical safety 113
- Hazardous materials 114
- Electromagnetic compatibility 115
- Electrostatic discharge 116
- Separation distance 117
- Labeling symbols 124
- Chapter 7: Safety 113 125
- STERILE R 126
- STERILE EO 126
- Chapter 7: Safety 115 127
- Specifications 128
- Standards 129
- Chapter 8: Acoustic Output 131
- Acoustic artifacts 132
- Acoustic Output 133
- Output display 135
- AIUM Medical Ultrasound 136
- Related guidance documents 137
- Acoustic output measurement 138
- -(0.23alf) 139
- -(0.069lf) 139
- Acoustic output tables 140
- CPD/Color 141
- PW Doppler 142
- Table 8: Transducer Model: 143
- Operating Mode: 143
- Table 9: Transducer Model: 144
- CW Doppler 146
- HFL38x/13-6 147
- Table 15: Transducer Model: 150
- Table 16: Transducer Model: 151
- Table 20: Transducer Model: 155
- Operating Mode: 155
- L38xi/10-5 159
- L38xi/10-5 161
- CPD/Color 161
- PW Doppler 162
- Table 28: Transducer Model: 163
- Table 29: Transducer Model: 164
- Table 32: Transducer Model: 167
- Table 33: Transducer Model: 168
- 4 WoITA z 176
- Glossary 179
- Abbreviations 181
- Numerics 191
- See also 192
- *P15200-01* 198
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