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i-4
Vscan Extend
–
User Manual
5721203-100
Rev. D
Certifications
•
GE Vingmed Ultrasound is ISO 13485 certified.
ISO10993-1
Biological evaluation of medical devices
EN 300 328
Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband transmission systems
ISO 14971
Medical devices - Application of risk management to medical
devices
IEC* 62304
Medical device software - Software life-cycle processes
IEC* 62366
Medical devices - Application of usability engineering to
medical devices
IEC* 60601-1-11
Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC* 60601-1-12
Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency
medical services environment
* including national deviations
Table i-1:
Regulatory Requirements (Continued)
Standard/Directive
Scope
Summary of Contents for Vscan Extend
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Page 56: ...Safety 2 30 Vscan Extend User Manual 5721203 100 Rev D ...
Page 94: ...Preparing Vscan Extend for Use 3 38 Vscan Extend User Manual 5721203 100 Rev D ...
Page 212: ...Vscan Extend Maintenance 6 18 Vscan Extend User Manual 5721203 100 Rev D ...
Page 226: ...Appendix 7 14 Vscan Extend User Manual 5721203 100 Rev D ...
Page 248: ...Privacy and Security 8 22 Vscan Extend User Manual 5721203 100 Rev D ...
Page 251: ......