Institutional Controls - Terumo Advanced Perfusion System 1 Operator's Manual

System Overview

Institutional Controls

WARNING: 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.
To reduce the likelihood of such errors, user institutions should establish policies or
procedures for developing, qualifying, controlling, maintaining and securing perfusion
screen configurations. The following list includes suggested actions to be covered by
such procedures. This is not intended as an all-inclusive list of actions, but is merely
a guide to illustrate examples of what an institution should consider when using
System 1. Additional or different actions may be necessary depending on particular
use and/or institutional policies and procedures.
Suggested policies and/or procedures to be established:
•
Authorization of appropriately qualified individuals to create, revise and approve
Perfusion Screens.
•
Use of passwords to prevent unauthorized changes to Perfusion Screens.
•
Testing methods to assure all system responses are completely understood and
meet expectations.
•
Establishment of protocols or methods for responding to situations that may
occur during use.
• Establishment of a standard system direction for roller pump forward flow.
• Establishment of a policy to re-set the roller pump default direction to the
institution's chosen standard system direction. This particularly applies to
replacement, loaner or returned pumps.
•
Training of users.
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