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Electrical Safety
Type CF Equipment: The heart symbol with the paddles on each side indicates that the
patient interface module meets all requirements for International Electrotechnical
Commission 60601-1 type CF classification. This device is protected against the voltages
of defibrillation, however, it is recommended to disconnect the catheter or pressure wire
from the patient interface module prior to defibrillation. If medically possible, remove the
catheter from the patient prior to defibrillation.
System has to be installed to IEC 60601-1, including the use of an isolation transformer
and potential equalization on control console and workstation.
Environmental Conditions
Temperature,
o
F
Temperature,
o
C
Humidity, % non-
Altitude, ft Altitude, m
Storage* -4 to 158 -20 to 70 5-80 — —
*As per IEC 60601-1, section 7.2.17.
DICOM Image Storage
Saving patient cases to DVD: The archived images are stored in DICOM format with
the Volcano system acting as a File Set Creator (FSC), following the guidelines in the
2004 DICOM 3.0 specification.
The DICOM images will be stored using the Ultrasound Application Profile STD-US-
SC-MF-DVD, using the UIDs in the following table.
Information Object
Definition
Ultrasound Multi-frame
Image Storage
1.2.840.10008.5.1.4.1.1.3.
1
1.2.840.10008.1.2.4.50