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Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)
1
Intended Use
INTENDED USE
The
Synclara™ Cough System
is intended for use on patients who are
unable to cough or clear secretions effectively due to reduced peak cough
expiratory flow, as a result of high spinal cord injuries, neuromuscular
deficits, or severe fatigue associated with intrinsic lung disease.
I
NTENDED
P
ATIENT
P
OPULATION
The Synclara™ Cough System, when used as a Synclara™ Cough System, is
intended to deliver therapy to the population of pediatric to adult
patients.
INTRODUCTION
This manual includes instructions for setup, use, and maintenance of the
Synclara™ Cough System, Model PSC1. Before you operate the system,
make sure you have read and understand in detail the contents of this
manual. It is important that you read and strictly obey the safety aspects
contained in this manual.
NOTE:
To identify the revision of your system, see the serial number label on the
back of the control unit.
IMPORTANT INFORMATION
This section contains information about the Synclara™ Cough System:
•
Theory of operation (See page 1)
•
Indications for Use (See page 2)
•
Contraindications (See page 3)
It is important that you read and understand the information in this
section before you use the system.
T
HEORY OF
O
PERATION
The Synclara™ Cough System provides a noninvasive therapy that is a safe
alternative to invasive suctioning. The system is designed for use by
patients, caregivers, and healthcare providers. The system will simulate a
cough to remove secretions in patients with a compromised peak cough
flow.
The system supplies positive insufflatory pressure (Inhale) to the airway
with the intended goal of inflating the lungs. The system then rapidly
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