HeartMate Universal Battery Charger IFU 30
Declaration Concerning General Safety Standards
Type
Degree of Protection
Mode of Operation
Continuous
Type of protection against electrical
shock
Class I (grounded)
Degree of protection against electric
shock
No Applied Part
Degree of safety of application in
the presence of a flammable
anesthetic mixture with air or with
oxygen or nitrous oxide.
Equipment not suitable for use in
the presence of a flammable
anesthetic mixture with air or with
oxygen or nitrous oxide.
Degree of protection against
harmful ingress of water
IPX0
Medical Electric Equipment
with respect to shock, fire,
mechanical and other specified
hazards only in accordance with
UL 60601-1 and 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)
For more information on Compliance and EMC testing, please refer to the following
LVAS System Manuals:
•
HeartMate II LVAS Operating Manual
(document #103884)
•
HeartMate XVE LVAS Operating Manual
(document #103887)
Manuals for HeartMate power accessories include:
•
HeartMate 12 Volt NiMH Battery Instructions for Use (IFU)
(document # 103769)
•
HeartMate 14 Volt Li-Ion Battery IFU
(document # 103770)
•
HeartMate Universal Battery Charger IFU
(document # 103771)
•
HeartMate Power Module IFU
(document # 103772)
