Volcano CORE Mobile, Operator'S Manual

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Page 122 of 148 300004969171/B
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
Relative
Humidity, % non-
condensing
Altitude, ft Altitude, m
Operating 50 to 104 10 to 40 5-80 10,000 3,048
Storage* -4 to 158 -20 to 70 5-80 — —
Shipping* 60 to 140 16 to 60 5-80 35,000 10,668
*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
SOP CLASS UID Transfer Syntax UID
DICOMDIR 1.2.840.10008.1.3.10 1.2.840.10008.1.2.1
Ultrasound Multi-frame
Image Storage
1.2.840.10008.5.1.4.1.1.3.
1
1.2.840.10008.1.2.1
1.2.840.10008.1.2.4.50