SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 20
8.0 Circulatory Support System (CSS) User’s Manual
The Circulatory Support System (CSS) User’s Manual, Part #950001, contains
detailed information on the setup, operation and troubleshooting of the SynCardia
TAH-t system. A brief description of the contents is given as a reference.
Introduction to the External Console:
Describes the system overview,
indications for use, and warnings.
Features and Operations:
Describes the operation of the controller, power
supply, air supply, vacuum pump, UPS, alarms and computer.
Unpacking and Initial Setup:
Covers unpacking instructions and initial setup.
Performance Verification:
Describes the console test procedure and the
preparation for standing by for an implant.
Clinical Use:
Describes console operation, readying system for clinical use,
SynCardia TAH-t startup, patient transport, transfer to backup controller, and
console replacement.
Specifications:
Describes the SynCardia TAH-t physical and performance
specifications.
Routine Maintenance and System Checkout:
Describes console
checkout,
batteries, cleaning, and checkout procedure.
Field Service Guide:
Describes air tank replacement, scheduled servicing, air
tank connector O-ring replacement, controller pilot pressure calibration,
controller replacement, fuse replacement, inactive storage, and crating
instructions.
8.1
Warnings for Console Operation
•
DO NOT
operate or adjust system without proper training.
•
DO NOT
operate console on an air supply of substandard or unknown
quality, either from tanks or in-house compressors.
•
DO NOT
use a controller outside of its planned maintenance cycle.
•
DO NOT
intentionally operate a system having only one functional
controller for any longer than is necessary to switch systems.
•
DO NOT
defeat the alarm system by turning it off, tampering with the
alarm mute button, by muffling the audible alarms, or by any other
means.
•
DO NOT
expose the system to any unusual environment, i.e. electric
or magnetic fields, dampness or temperature extremes.
