i-2
Vivid S70 / S60
–
User Manual
BC092760-1EN
01
Regulatory Requirements
Conformance Standards
The GE Healthcare product families are tested to meet all
applicable requirements and relevant standards per the
countries in which the product will be sold. Any changes to
accessories, peripheral units, or any other part of the system
must be approved by the manufacturer: GE Vingmed Ultrasound
AS. Ignoring this advice may compromise the regulatory
approvals obtained for the product.
This product complies with the regulatory requirements of the
following:
Standard/Directive
Scope
93/42/EEC
Medical Devices Directive (MDD)
2012/19/EU
Waste Electrical and Electronic Equipment (WEEE)
2011/65/EU
Directive on the restriction of the use of certain hazardous substances in
electrical and electronic equipment (ROHS)
IEC/EN 60601-1
ANSI/AAMI ES60601-1
CAN/CSA-C22.2 No. 60601-1
Medical Electrical Equipment - Part 1. General requirements for basic
Safety and essential performance
IEC/EN 60601-2-37
Medical electrical equipment - Part 2-37. Particular requirements for the
basic safety and essential performance of ultrasonic medical diagnostic
and monitoring equipment
IEC/EN 60601-1-2
Medical Electrical Equipment - Part 1-2. General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
IEC/EN 60601-1-6
Medical Electrical Equipment - Part 1-6. General requirements for basic
safety and essential performance - Collateral standard: Usability
NEMA/AIUM UD-3
Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment.
IEC/EN 62304
Medical Device Software - Software life-cycle processes
IEC/EN 62366
Medical Devices - Application of usability engineering to medical devices
ISO 10993-1
Biological evaluation of medical devices
Содержание Vivid S70
Страница 8: ...i 6 Vivid S70 S60 User Manual BC092760 1EN 01...
Страница 62: ...Safety 2 30 Vivid S70 S60 User Manual BC092760 1EN 01 For China only...
Страница 63: ...Device labels Vivid S70 S60 User Manual 2 31 BC092760 1EN 01...
Страница 64: ...Safety 2 32 Vivid S70 S60 User Manual BC092760 1EN 01...
Страница 140: ...Image Optimization 5 4 Vivid S70 S60 User Manual BC092760 1EN 01 Figure 5 2 2D Touch panel 4D probe Live page 1 and 2...
Страница 144: ...Image Optimization 5 8 Vivid S70 S60 User Manual BC092760 1EN 01 Figure 5 4 M Mode Touch panel page 1 and 2...
Страница 149: ...Color Mode Vivid S70 S60 User Manual 5 13 BC092760 1EN 01 Figure 5 6 Color 2D Touch panel page 1 and 2...
Страница 156: ...Image Optimization 5 20 Vivid S70 S60 User Manual BC092760 1EN 01 Figure 5 10 The PW Doppler Touch panels page 1and 2...
Страница 160: ...Image Optimization 5 24 Vivid S70 S60 User Manual BC092760 1EN 01 Figure 5 12 TVI Touch panel page 1 and 2...
Страница 163: ...Tissue Tracking Vivid S70 S60 User Manual 5 27 BC092760 1EN 01 Figure 5 14 The Tissue Tracking Touch panel page 1 and 2...
Страница 166: ...Image Optimization 5 30 Vivid S70 S60 User Manual BC092760 1EN 01 Figure 5 16 The Strain rate Touch panel page 1 and 2...
Страница 169: ...Strain Vivid S70 S60 User Manual 5 33 BC092760 1EN 01 Figure 5 18 The Strain Touch panel page 1 and 2...
Страница 172: ...Image Optimization 5 36 Vivid S70 S60 User Manual BC092760 1EN 01 Figure 5 20 The TSI Touch panel page 1 and 2...
Страница 215: ...4D Mode Vivid S70 S60 User Manual 6 15 BC092760 1EN 01 Figure 6 9 The 4D Color Flow mode Touch panel...
Страница 280: ...Measurements and Analysis 8 2 Vivid S70 S60 User Manual BC092760 1EN 01 Measurement accuracy on page 8 97...
Страница 297: ...Advanced cardiac measurements and analysis Vivid S70 S60 User Manual 8 19 BC092760 1EN 01 Figure 8 9 AFI workflow...
Страница 349: ...4D Auto MVQ Vivid S70 S60 User Manual 8 71 BC092760 1EN 01 Figure 8 37 Set Landmark stage...
Страница 382: ...Measurements and Analysis 8 104 Vivid S70 S60 User Manual BC092760 1EN 01...
Страница 457: ...Disk management Vivid S70 S60 User Manual 10 55 BC092760 1EN 01 8 Press OK See page 10 56 to perform a database backup...
Страница 479: ...Working with the report function Vivid S70 S60 User Manual 11 5 BC092760 1EN 01 Figure 11 1 The Report screen...
Страница 670: ...Probes 13 54 Vivid S70 S60 User Manual BC092760 1EN 01...
Страница 704: ...Maintenance 15 14 Vivid S70 S60 User Manual BC092760 1EN 01...
Страница 708: ...Index 4 Vivid S70 S60 User Manual BC092760 1EN 01...
Страница 709: ......