Thoratec HeartMate III User manual

Alarms for Clinicians
For additional information and
guidelines, refer to the
HeartMate
III Instructions for Use.
Thoratec Corporation
6035 Stoneridge Drive, Pleasanton, CA 94588
Tel [phone] | Fax [phone]
HeartLine [phone]
www.thoratec.com
European Authorized Representative
St. Jude Medical
Coordination Center BVBA. The Corporate Village
Da Vincilaan 11 Box F1. 1935 Zaventem, Belgium
Tel [phone] | 24-Hr Tel [phone]
Thoratec Corporation continually strives to provide the highest quality
products for mechanical circulatory support. Specifications may change
without notice. Therefore, please refer to the HeartMate III Instructions for
Use shipped with the HeartMate III for the most current information regarding
indications, contraindications, warnings, and cautions. Thoratec, the Thoratec
logo, and HeartMate are registered trademarks, and HeartMate III, Mobile
Power Unit, and HeartLine are trademarks of Thoratec Corporation.
©2017 Thoratec Corporation. 10009740.A 10/2017
Alarm Means
IMPORTANT! The Pump Running ( ) light is always green (ON) when the pump is running.
1Check if the fixed speed setting
is below 4,000 rpm AND the
System Controller’s backup battery
is not installed. Under these
conditions, the pump can only
be started from the System Monitor’s
Clinical or Settings screen by
pressing the Pump Start button.
Otherwise, press any button on
the System Controller to attempt
pump start.
1Ensure that the Driveline is
connected to the System Controller.
2Ensure that a power
source is connected to
the System Controller.
3Clinically evaluate the patient.
+
Low flow, flow is
less than 2.5 lpm
Driveline is
disconnected.
The Pump Running
symbol is black.
Both power cables
are disconnected.
System Controller
Hardware Fault
(Microcontroller
Failure)
Pump is off.
The Pump Running
symbol is black.
3If the alarm still persists, check
if the fixed speed setting is below
4,000 rpm AND the System
Controller’s backup battery is not
installed. Under these conditions,
from the System Monitor’s Clinical
or Settings screen by pressing
the Pump Start button.
4If the Driveline is connected and
the alarm persists, replace the
System Controller with a configured
Immediately connect to a working power source
(Power Module, Mobile Power Unit, or two fully-charged
HeartMate 14 Volt Lithium-Ion batteries).
Immediately connect to a working power source
(Power Module, Mobile Power Unit™, or two HeartMate®
14 Volt Lithium-Ion batteries).
Priority
System Controller
ScreenActive SymbolsTo Resolve Alarm
HAZARD
+
Low Battery,
Power Input is extremely
low with less than 5 min.
remaining.
1Immediately reconnect the
Driveline to the System Controller
and move the Driveline safety
lock on the System Controller
to the locked position. Also check
that the Modular In-Line connector
is secure.
2If the alarm persists after
reconnecting the Driveline,
press any button on the System
Controller to attempt pump start.
1Immediately switch to the backup System Controller.
2 Provide the patient with a new System Controller.
No active symbols (constant audio tone).
2Switch to the backup
System Controller and
attempt to restart the pump.
3Clinically evaluate the patient.
+
+
+
+
+

IMPORTANT! The Pump Running ( ) light is always green (ON) when the pump is running.
Promptly connect the disconnected power cable to power source (functioning Power Module, MobilePower
Unit, or two fully-charged HeartMate®14 Volt Lithium-Ion batteries).
System Controller Hardware Fault
System Controller Backup Battery Fault
Communication Fault (Comm Fault)
System Controller Backup Battery
Not Installed
Driveline Communication Fault (Driveline
Comm Fault)
Driveline Power Fault
One of the two power cables
is disconnected.
1 Switch to the backup System Controller.
Refer to Guide to Replacing theRunning
System Controller for Clinicians.
Replace the 11 Volt Lithium-Ion backup battery.
Note:If replacing the battery does not resolve the alarm, the System Controller may need to be
replaced or additional steps may be required. Call Thoratec Corporationwith questions.
Note:If replacing the battery does not resolve
the alarm, the System Controller may need to be
replaced oradditional steps may be required.
Call Thoratec Corporation with questions.
Contact Thoratec to determine best nextsteps:
Use the System Monitor to silence the alarm while awaiting resolution, if needed.
Note: The alarm must be active to access the extended alarm silence for this situation.
Contact Thoratec Corporation to determine best next steps.
Use the System Monitor to silence the alarm while awaiting resolution, if needed.
Note: The alarm must be active in order to access the alarm silence for this situation.
Contact Thoratec Corporation to determine best next steps.
Use the System Monitor to silence the alarm while awaiting resolution, if needed.
Note: The alarm must be active to access the alarm silence for this situation.
2Provide the patient with a new
System Controller (with backup battery
installed).
1Install the 11 Volt Lithium-Ion backup battery
in the System Controller.
2Obtain a new backup battery replacement kit.
Priority
+
+
ADVISORY
Ensure the power cables are connected correctly:
white-to-white, black-to-black.
Note: The second condition (meaning / resolution) will not apply for MobilePower Units
with Software version 1.02.
Low Battery, Power input is low,
with less than 15 min. remaining.
System Controller power cables are crossed
when connected to the Mobile Power Unit.
OR
OR
System Controller
ScreenAlarm Means
Active
SymbolsTo Resolve Alarm
Promptly connect to a working or different power source
(Power Module, Mobile Power Unit, or two fully-charged
HeartMate14 Volt Lithium-Ion batteries).
OR