Terumo 801763, Operator'S Manual, Page: 15 / 359

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About Advanced Perfusion System 1
Indications and Warnings
Indications
The Terumo
®
Advanced Perfusion System 1 is indicated for use for up to 6 hours in
the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and
cardiopulmonary bypass procedures, when used by a qualified medical professional
who is experienced in the operation of this or similar equipment.
The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.
Contraindications
This device is not designed, sold or intended for use except as indicated.
The centrifugal pump is contraindicated for use as a cardiotomy suction device.
User Qualifications
Proper perfusion procedures and techniques are the responsibility of the medical
professional.
User must read and understand all information in the Operators Manual for the
Terumo
®
perfusion system being used.
System Warnings
The System 1 is indicated for use for up to 6 hours duration. The safety and
effectiveness of System 1 for long-term use (longer than 6 hours duration) has not
been established.
Use the system and any attached equipment according to the manufacturer’s
instructions and good medical practice.
This device is qualified only for durations appropriate to cardiopulmonary bypass
procedures. It has not been qualified, through
in vitro , in vivo , or clinical studies, for
long-term use in bridge to transplant or pending recovery of the natural heart.
Do not use an apparently malfunctioning device in an operation.
Do not modify the Advanced Perfusion System 1 or any attached equipment or
accessories. Only use spare parts provided by Terumo Cardiovascular Systems.
Modifying the system, using unapproved spare parts, or using the system in ways
not indicated by this manual could lead to injury, compromised performance, and/or
damage.
This device must not be allowed to run unattended. Patient safety requires that
operation be properly and continuously monitored by a qualified medical professional.
System 1 is a configurable system allowing users to create perfusion screens utilizing
different combinations of equipment with different responses to events. Because
of this high degree of configurability, it is important that user institutions establish
appropriate controls to assure that users are properly trained and qualified to run
Perfusion Screens.
Failure to establish such controls may result in operator
error that could result in patient injury or death.