Resonance Imaging (MRI), as the pump contains ferro-magnetic components,
and MRI could cause device failure or patient injury.
·
Do NOT apply high power electrical treatment (e.g., application of diathermy)
directly to the patient.
·
Disconnecting the HeartMate II LVAS from the System Controller is advised
during open heart defibrillation due to the proximity of the paddles to the
device. However, the LVAS should NOT be disconnected during
external
defibril-
lation.
·
The implanted components of the LVAS should NOT be exposed to therapeutic
levels of ultrasound energy (e.g., ultrasound heating and/or extracorporeal
shockwave lithotripsy) used to alter or albate tissues, as the device may inadver-
tently concentrate the ultrasound field and cause harm to the patient. This does
NOT apply to diagnostic techniques, such a echocardiography.
·
Therapeutic ionizing radiation may damage the device, which may not be
immediately detectable.
·
Avoid strong static discharges (e.g., from touching television or computer moni-
tor screens, vacuuming carpets, etc.) as this can damage the electrical parts of
the system and cause the LVAD to stop.
·
To prevent device damage and personal injury, refer servicing to authorized
service personnel trained by Thoratec corporation.
Warnings Specific to Patient or System Management
·
System components must never be immersed in water or liquid. Showers and
washing are permitted when the clinician approves wound site readiness.
During showers, the HeartMate Shower Kit must be used.
·
In the event that the LVAD stops operating, attempt to restore pump function
immediately. In the event that the LVAD stops operating and blood is stagnant
in the pump for more than a few minutes (depending on the coagulation status
of the patient), there is a risk of stroke or thromboembolism should the device
be restarted. There is also the potential for retrograde flow within the LVAD.
·
Disconnecting both System Controller power leads at the same time will result
in loss of pump function. One System Controller power lead must be connected
to a power source (i.e., batteries, PBU, or EPP) at all times to maintain support.
The following will cause the LVAD to stop and blood pumping to cease:
-
Disconnecting both power leads from the PBU when operating on PBU
power.
-
Removing both batteries from their respective battery clips when operating
on battery power.
-
Completely depleting all battery charge when operating on battery power.
·
Disconnecting the percutaneous lead from the System Controller will result in
loss of pump function. The System Controller must be reconnected as quickly
as possible to resume pump function:
CLINICAL OPERATION AND PATIENT MANAGEMENT
3
