Q00180 Rev B
Page 27 of 244
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3.13 Safety Standards
All ZONARE instruments, cables, and diagnostic ultrasound imaging transducers have been designed
to meet the essential requirements contained in:
•
93/42/EEC (Medical Device Directive).
In addition, all the above listed equipment meets the following appropriate requirements:
•
UL 60601-1 (Standard for Medical Electrical Equipment Part 1: General Requirements for
Safety)
•
IEC 60601- (Medical Electrical Equipment Part 1: General Requirements for Safety)
•
JIS-T-1001 (General Requirements of Medical Electrical Equipment), including limits for
current leakage and isolation from a primary power line
•
Testing for compliance with the essential requirements of the Medical Device Directive has
been performed.
The
Z.ONEULTRA SP
meets the acoustic output emission guidelines established by the U.S. Food
and Drug Administration (FDA). Acoustic output quantities have been measured, and are displayed, in
accordance with the standards listed under “Guidance Documents”.
3.14 DICOM Standard
•
NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15:
Security Profiles
3.15 Product Labeling
The following figures depict the labeling that is required by various regulatory authorities, and
describe their location.
Contact ZONARE if any of these labels are missing or damaged beyond legibility. The
Z.ONEULTRA
SP
labels herein are for reference only and are not shown to scale.
Figure 1: Label, Scan Module – Serial/Part No.
Содержание Z.one Ultra SP
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