Safety
9-19
Immunity testing requirements
TheSonoSite X-Porte ultrasound system complies with the essential performance requirements specified in
IEC 60601-1-2 and IEC 60601-2-37. Results of immunity testing show that the SonoSite X-Porte ultrasound
system meets these requirements and is free from the following:
Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value that
cannot be attributed to a physiological effect and that may alter the diagnosis
Display of incorrect numerical values associated with the diagnosis to be performed
Display of incorrect safety related indications
Production of unintended or excessive ultrasound output
Production of unintended or excessive transducer assembly surface temperature
Production of unintended or uncontrolled motion of transducer assemblies intended for intracorporeal use
Labeling Symbols
The following symbols are used on the products, packaging, and containers.
Table 9-5: Labeling Symbols
Symbol
Definition
Alternating Current (AC)
Class 1 device indicating manufacturer’s declaration of conformance with Annex
VII of 93/42/EEC
Class 1 device requiring verification by the Notified Body of sterilization or
measurement features, or to a Class IIa, IIb, or III device requiring verification or
auditing by the Notified Body to applicable Annex(es) of 93/42/EEC
Attention, see the user guide
Reading the accompanying documentation is necessary for safe operation of the
medical device.
Содержание SONOSITE X-PORTE
Страница 1: ...USER GUIDE ...
Страница 75: ...Setting up the system 3 39 ...
Страница 76: ...3 40 Setting up the system ...
Страница 128: ...4 52 Imaging ...
Страница 186: ...5 58 Measurements and calculations ...
Страница 210: ...6 24 Measurement references ...
Страница 234: ...8 16 Cleaning and disinfecting ...
Страница 262: ...9 28 Safety ...
Страница 334: ...10 72 Acoustic output ...
Страница 364: ...B 14 Index printing 5 56 zoom 4 23 ...
Страница 365: ......
Страница 366: ...P14645 05 P14645 05 ...