Q00110 Rev A 8/06
Page 31 of 225
"Note: Copies are uncontrolled documents - For revision verification see the Master Documentation List"
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IEC 60601- (Medical Electrical Equipment Part 1: General Requirements for Safety)
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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.one
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”.
3.15 DICOM Standard
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NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15:
Security Profiles
3.16 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.one
labels
herein are for reference only and are not shown to scale.
Figure 1: Label, Scan Engine – Serial/Part No.
Figure 2: Label, Battery - Model/Serial No.
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