CLINICAL OPERATION AND PATIENT MANAGEMENT
4
-
For pump speeds <8,000
(typical at time of device implantation), recon-
nect the System Controller and then firmly press the Silence Alarm or Test
Select button as quickly as possible to resume pump function.
-
For pump speeds >8,000
(typical post implant), reconnect the System
Controller as quickly as possible to resume pump function. The pump
should automatically resume pumping once power is restored.
General Precautions
·
Refer to the
HeartMate II LVAS Instructions for Use
and the
HeartMate II LVAS
Operating Manual
for detailed instructions and information on device implant
and system setup, function, and maintenance. These manuals are not intended
to replace comprehensive laboratory or educational programs, or to supercede
appropriate medical judgment, however.
·
Patients with mitral or aortic mechanical valves may be at added risk of accu-
mulating thrombus on the valves when supported with left ventricular assist
devices.
·
Only use Thoratec Corporation's PBU to charge batteries. Other battery chargers
may damage HeartMate batteries.
·
Do NOT use batteries below 15
o
F (-10
o
C) or above 105
o
F (40
o
C) or they may fail
suddenly. If batteries are below room temperature (68-72
o
F, 20-23
o
C) during use,
their capacity will be reduced. At the low end of the temperature range (15
o
, -
10
o
C), run time will be reduced by 50%.
·
Use of expired or defective batteries may result in reduced operating time or
abrupt loss of pump function.
·
Dispose of expired, used, or damaged batteries according to local, state or feder-
al regulations. Do not incinerate.
·
The use of other electronic devices (medical or non-medical) that do not com-
ply with the equivalent safety requirements of the PBU may lead to reduced
patient safety. When considering whether or not to use an electronic device on
or near the patient:
·
Confirm that the safety certification of the accessory has been performed in
accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmo-
nized national standard.
·
Use only those devices necessary for patient safety and well-being.
·
Do not store or use the Emergency Power Pack (EPP) below 32
o
F (0
o
C) or above
122
o
F (50
o
C) or it may fail suddenly. If the EPP is below room temperature (68-
72
o
F, 20-23
o
C) during use, it will run the pump for less than 10 hours. At the low
end of the temperature range (32
o
F, 0
o
C), run time will be reduced by 50%.
·
To prevent deterioration or damage to the EPP:
·
Do not leave or store the EPP in hot or cold areas (car trunk, etc.) or battery
life will be shortened.
·
Do not use the EPP beyond the expiration date.
·
Dispose of an expired, used, or damaged EPP according to local, state or fed-
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