SynCardia Companion 2 Driver System, Operator'S Manual

Page: 21 / 134

SynCardia Systems, LLC
Companion 2 Driver System Operator Manual
Page 21 of 132
Chapter 5. Precautions
5.1 Surgical, nursing, and perfusion staff responsible for the SynCardia TAH-t
program at each hospital must complete the SynCardia Certification
program.
5.2 The SynCardia TAH-t and Drivelines are provided sterile; caution must be
taken in opening the package. Do NOT resterilize. Do NOT use if
package is damaged. Storage temperature for the Drivelines is 10 - 50°C.
5.3 Measures should be taken to prevent infection or sepsis. Use strict aseptic
techniques during implantation.
5.4 The outflow grafts must be pre-clotted before use.
5.5 Do not use an antifibrinolitic agent like Amicar with an active clotting agent
like FEIBA.
5.6 Each Companion 2 Driver contains two independent compressor
subassemblies, each capable of providing independent support for
operation of the TAH-t. Hospitals, and patients supported with the
Companion 2 Driver, must have an additional Companion 2 Driver
available as a backup to be used in the event of a failure of the primary
Companion 2 Driver.
Always program the correct settings for the backup Driver when the
primary Driver is programmed.
Train personnel how to exchange the primary Companion 2 Driver with a
backup Companion 2 Driver in the event of system failure. Connect the
backup Companion 2 Driver as quickly as possible. This procedure is for
emergency use only. See Chapter 15 in this manual, Switching from
Primary Companion 2 Driver to Backup Companion 2 Driver.
5.7 It is recommended that the external air pressure for the Companion 2
Driver be maintained between 50 to 80 PSI (3.5 to 5.5 Bar). If the external
air pressure is below this range it will not impact the Driver functionality,
however, it may result in a System Malfunction Alarm. If a System
Malfunction Alarm is displayed while on external air, remove the external
air connection from the Driver and verify that the alarm clears. If the
external air pressure is above the specified range it will not impact the
Driver functionality, however, the internal compressor may activate
intermittently. When the compressor activates, the external air icon on the
display will not be illuminated.
5.8 The TAH-t System contains ferro-magnetic metal components. Do NOT
perform MRI imaging procedures on patients implanted with the TAH-t.
5.9 Manage the exit site in accordance with hospital procedures.
5.10 Use only water-soluble antiseptic cleaners around the exit site. Ointments
may delay tissue in-growth around the cannulae.
5.11 Monitor cardiac output when closing the chest. A reduction in TAH-t
output while closing the chest may indicate inflow obstruction. Reposition