HeartMate Universal Battery Charger IFU 29
7.0 Product Disposal
Dispose of (or recycle) used or damaged UBCs in compliance with all applicable
local, state, and federal laws and regulations. Talk with your VAD Coordinator or
hospital contact person for guidance, if needed.
8.0
Testing
and
Classification
The HeartMate UBC complies with the following safety standards:
•
IEC 60601-1:1998, 2
nd
Edition, A1:1991, A2:1995.
•
UL 60601-1, 1
st
Edition, 2006-04-26 (included National Differences for USA)
•
EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996
•
CAN/CSA C22.2 No.601.1-M90 (R1997), CAN/CSA C22.2 No.601.1S1-94,
and CAN/CSA C22.2 No.601.1B-98 (National Difference for Canada)
The HeartMate UBC has been tested and found to comply with the limits for
medical devices to the IEC 60601-1-2:2004. These limits are designed to provide
reasonable protection against harmful interference in a typical medical
installation. The UBC is an unintentional radiator of radio frequency energy and,
if not installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If the HeartMate UBC does
cause harmful interference to other devices, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
•
Reorient or relocate the receiving device.
•
Increase the separation between the equipment.
•
Connect the equipment into an outlet on a circuit different from that to which
the other device(s) are connected.
•
Consult Thoratec Technical Service for assistance.
