Terumo 801763, Operator'S Manual, Page: 312 / 359

12-1
Additional Information
Summary of Warnings and Precautions
System Warnings
Use the system and any attached equipment according to the manufacturer’s
instructions and good medical practice.
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.
Do not use an apparently malfunctioning device in an operation.
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.
System Equipment Precautions
Grounding reliability can only be achieved when this equipment is connected to an
appropriate receptacle which has been inspected for proper grounding.
This device requires a dedicated 20 Amp AC (Mains) power source for the 100V –
120V model or a dedicated 10 Amp AC (Mains) power source for the 220V – 240V
model.
Complete any external equipment connections before turning the system on as
connecting equipment during use may cause system malfunction.
Do not use this device in the presence of explosive or flammable gases.
To avoid electrical shock hazard, do not remove panels. Refer servicing to qualified
service personnel.
Do not operate the system without the module covers secured in place as spilled
liquids may damage the connections.
Connect only hospital equipment of appropriate voltage and current rating to the
auxiliary outlet.
The auxiliary outlet is not backed up by battery power. During loss of AC (Mains)
power, any equipment connected to the auxiliary outlet will lose power and remain
unpowered until AC (Mains) power is restored.
Do not use extension cords to connect the system to AC (Mains) power nor to
connect modules or accessories to the system. Use of extension cords may
compromise performance.