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9-26
Safety
EMC standards classification
The Classification for the ultrasound system, docking system, accessories, and peripherals when configured
together is: Group 1, Class A.
DICOM standard
NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles.
The system conforms to the DICOM standard as specified in the SonoSite X-Porte DICOM Conformance
Statement, available at
. This statement provides information about the purpose,
HIPAA standard
The system includes security settings that help you to meet the applicable security requirements listed in
the HIPAA standard. Users are ultimately responsible for ensuring the security and protection of all electronic
protected health information collected, stored, reviewed, and transmitted on the system.
IEC 60601-1-6:2013
Medical Electrical Equipment part 1-6: General requirements for basic safety
and essential performance – Collateral Standard: Usability (Edition 3.1b)
CSA C22.2
60601-2-37:08
Medical Electrical Equipment – Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment (Adopted IEC 60601-2-37:2007, Edition 2.0)
CSA C22.2
60601-1-6:11+A1
Medical Electrical Equipment part 1-6: General requirements for basic safety
and essential performance – Collateral Standard: Usability (Adopted IEC
60601-1-6:2013, Edition 3.1)
Table 9-7: EMC standards classification
Standard
Description
IEC 60601-1-2:2007
Medical Electrical Equipment. General Requirements for Basic Safety and
Essential Performance-Collateral Standard. Electromagnetic Compatibility.
Requirements and Tests.
CISPR 11:2009
Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment
Electromagnetic Disturbance Characteristics-Limits and Methods of
Measurement.
Table 9-6: Electromechanical safety standards (continued)
Standard
Description
Summary of Contents for SONOSITE X-PORTE
Page 1: ...USER GUIDE ...
Page 75: ...Setting up the system 3 39 ...
Page 76: ...3 40 Setting up the system ...
Page 128: ...4 52 Imaging ...
Page 186: ...5 58 Measurements and calculations ...
Page 210: ...6 24 Measurement references ...
Page 234: ...8 16 Cleaning and disinfecting ...
Page 262: ...9 28 Safety ...
Page 334: ...10 72 Acoustic output ...
Page 364: ...B 14 Index printing 5 56 zoom 4 23 ...
Page 365: ......
Page 366: ...P14645 05 P14645 05 ...