Zimmer Sonido Smart, Инструкция по эксплуатации, Страница: 172 / 173

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Appendix E: Maximum surface temperature for the transducer
In accordance with the requirements of section 42.3 of the standard IEC 60601-2-37:2007, the transducer surface
temperature was tested under two conditions: with the transducer suspended in still air and with the transducer in
contact with a simulated human tissue. The calculation of the expanded uncertainty was carried out based on the ISO
guideline for the expression of uncertainty in measurement. Three transducer samples were tested, and the confi-
dence limit is 95%, the value of t.975 is 4.30. The measured data was obtained under the test conditions used by
ZIMMER MEDIZINSYSTEME.
Transducer
Model
Maximum surface tem-
perature (°C)
C3-A
<41.0
V6-A
<41.0
L7M-A
<41.0
MC6-A
<41.0
L7S-A
<41.0