Hillrom Synclara PSC1 User manual

Synclara™ Cough System
Model PSC1
User Manual
Product No. PSC1
Rx only: Federal USA law restricts this device to sale by or on the order of a
physician.
194921 REV E
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Synclara™ Cough System, Model PSC1 User Manual (194921 REV E) i
REVISION
© 2019 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED.
PATENTS / PATENT www.hill-rom.com/patents
The Synclara™ Cough System, Model PSC1 may be covered by one or
more patents. See the Internet address above.
The Hill-Rom companies are the proprietors of European, US, and other
patents and pending patent applications.
Authorized European Union Representative:
REGULATORY AFFAIRS REPRESENTATIVE
WELCH ALLYN LIMITED
NAVAN BUSINESS PARK
DUBLIN ROAD
NAVAN, COUNTY MEAD,
REPUBLIC OF IRELAND
No part of this text shall be reproduced or transmitted in any form or by
any means, electronic or mechanical, including photocopying, recording,
or by any information or retrieval system without written permission from
Hill-Rom Services, Inc. (Hill-Rom).
The information in this manual is confidential and may not be disclosed to
third parties without the prior written consent of Hill-Rom.
The information in this manual is subject to change without notice. Hill-
Rom makes no commitment to update or keep current, the information in
this manual.
Hill-Rom reserves the right to make changes without notice in design,
specifications, and models. The only warranty Hill-Rom makes is the
express written warranty extended on the sale or rental of its products.
This manual (194921) was originally released and supplied in English. For
a list of available translations, contact Hill-Rom Technical Support.
Product images and labels are for illustrative purposes only. Actual
product and label may vary.
Draft E, 2019-04
First Printing, 2019
Manufactured by:
HILL-ROM SERVICES PRIVATE LIMITED
1 YISHUN AVENUE 7
SINGAPORE 768923
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ii Synclara™ Cough System, Model PSC1 User Manual (194921 REV E)
Bluetooth® is a registered trademark of Bluetooth Sig, Inc.
Hill-Rom® is a registered trademark of Hill-Rom Services, Inc.
Synclara™ is a trademark of Hill-Rom Services PTE Ltd .
Replace this manual (194921) if it is damaged and/or can not be read.
For product support or to order additional copies of this manual (194921),
contact your distributor, local Hill-Rom representative, or go to
www.hill-rom.com.
Reference Documents
Maximus™, Volara™, and Synclara™ Airway Clearance Systems Service
Manual (194922)
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Synclara™ Cough System, Model PSC1 User Manual (194921 REV E) iii
Table of Contents
Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Absolute Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Relative Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Possible Adverse Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Symbols and Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Document Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Product Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Common Screen Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Front. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Synclara™ Cough System Single Patient Use Circuit . . . . . . . . . . . 15
Assemble and Connect the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . 16
Connect the Synclara™ Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . 17
Set up and Power on the Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Power off the Control Unit and Store the System . . . . . . . . . . . . . . . . . . 19
Synclara™ Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
About the Home Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
About the Options Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Start a Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Synclara™ Therapy in Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . 23
Basic View in Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Start a Therapy in Automatic Mode . . . . . . . . . . . . . . . . . . . . . . 24
Adjust the Patient Synchrony and End with Sigh settings . 26
Access the Advanced View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
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iv Synclara™ Cough System, Model PSC1 User Manual (194921 REV E)
Synclara™ Therapy in Manual Mode. . . . . . . . . . . . . . . . . . . . . . . . . . 28
Start a Therapy in Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . 29
Advanced Synclara™ Therapy Settings . . . . . . . . . . . . . . . . . . . . . . . 32
Create a New Preset Therapy Plan . . . . . . . . . . . . . . . . . . . . . . . 32
Modify a Preset Therapy Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Rename a Preset Therapy Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Delete a Preset Therapy Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Device Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Adjust Screen Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Adjust Date and Time settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Change the System Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Enable or Disable Clinical Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Set the Pressure Ceiling Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Connect a Barcode Reader or Pulse Oximeter . . . . . . . . . . . . . . . . 45
Connect to a WIFI Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Connect to a Local WIFI Network . . . . . . . . . . . . . . . . . . . . . . . . 46
Connect to a Public Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Connect to an Enterprise Network . . . . . . . . . . . . . . . . . . . . . . . 49
Configure Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Test the Connection to VisiView™ Health portal . . . . . . . . . . 52
Test the Connection to Electronic Medical Records (EMR). 53
Retrieve Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Retrieve the Therapy Logs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Retrieve the Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Import and Export Device Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 57
View the Firmware Version and System Information . . . . . . . . . . 58
Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Replaceable Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Install the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Charge the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Pulse Oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Foot Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Mobile Stand and Pole Clamp Assembly . . . . . . . . . . . . . . . . . . . . . 66
Install the Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Install the Tray and Pole Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . 68
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Synclara™ Cough System, Model PSC1 User Manual (194921 REV E) v
Install the Control Unit on the Cart and Stand Assembly . . 69
Move the Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Install the Control Unit on a Medical Rail or IV pole . . . . . . . 70
Replacement Parts/Kits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Clean the Control Unit, Stand with Cart, and Foot Switch. . . . . . 74
Clean the Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Clean the Single Patient Use Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Disinfect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Inlet Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Expected Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Service calls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Control Unit Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
On-screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Information Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Audio Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Notification Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Warning Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Caution Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Shipping and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Shipping for Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Product Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Replaceable Battery (Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Environmental Conditions for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Environmental Conditions for Transport and Storage . . . . . . . . . 91
System Cool Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Wireless Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
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vi Synclara™ Cough System, Model PSC1 User Manual (194921 REV E)
Classification and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Federal Communications Commission (FCC) Compliance
Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Electromagnetic Compatibility Guidance . . . . . . . . . . . . . . . . . . . . 96
Electromagnetic Immunity to Wireless Communications . . . . 100
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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.
INTENDED PATIENT POPULATION
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.
THEORY OF OPERATION
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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2 Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)
Important Information
shifts to supply negative exsufflatory pressure (Exhale) with the intended
goal of rapidly deflating the lungs to simulate a high expiratory flow
which stimulates an effective cough. After exhale, the system moves into a
paused state and maintains a positive pressure flow to the patient, if
programed. This is referred to as Positive Airway Pressure on Pause (PAP).
An optional Sigh stage can also be included after the therapy to inflate the
patient’s lungs after the last exhale of the therapy.
INDICATIONS FOR USE
The Synclara™ Cough System is indicated for, but is not limited to
patients with these conditions:
• Muscular dystrophy
• Spinal muscular atrophy
• Amyotrophic lateral sclerosis
• Spinal cord injuries
• Myasthenia gravis
• Post polio
• COPD patient with a weak and ineffective cough
CONTRAINDICATIONS
CONTRAINDICATION:
Contraindication—If patient conditions exist that cause the use of the
system to be a risk to the patient, do not use the unit. Death or serious
injury could occur.
ABSOLUTE CONTRAINDICATIONS
The Synclara™ Cough System is contraindicated if these patient conditions
exist:
• History of bullous emphysema, known susceptibility to
pneumothorax, or pneumo-mediastinum, or known to have had any
recent barotraumas
• Severe airway obstruction
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Synclara™ Cough System, Model PSC1 User Manual (196286 REV E) 3
Important Information
RELATIVE CONTRAINDICATIONS
When you use the Synclara™ Cough System, patients with these
conditions should be carefully evaluated before a decision is made to use
the therapy:
• Inability to tolerate the increased work of breathing
• Hemodynamic instability
• Intracranial pressure (ICP) > 20 mm Hg
• Acute sinusitis
• Recent facial, oral, or skull surgery or trauma
• Epistaxis
• Esophageal surgery
• Active hemoptysis
• Nausea
• Known or suspected tympanic membrane rupture or other middle ear
pathology
POSSIBLE ADVERSE CONDITIONS
When using the Synclara™ Cough System, patients may experience one or
more of these effects:
• Increased work of breathing leading to hypoventilation and
hypercarbia.
• Cardiovascular compromise such as myocardial ischemia and
decreased venous return.
• Swallowing too much air resulting in the likelihood of vomiting and
aspiration.
• Claustrophobia.
• Skin break down and discomfort from face mask.
• Pulmonary barotraumas.
• Disruption of the healing process on patients who have had recent
surgical procedures. Muscle contractions during the therapy could
disrupt the healing process.
NOTE:
Patients with cardiac instability should be monitored closely for pulse and
oxygen saturation.
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4 Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)
Symbols and Acronyms
SYMBOLS AND ACRONYMS
DOCUMENT SYMBOLS
This manual contains different typefaces and symbols to make the
content easier to read and understand:
• Standard text—used for regular data.
•Boldface text—emphasizes a word or phrase.
•NOTE:—sets apart special data or important instruction clarification.
• CONTRAINDICATION, WARNING or CAUTION
– A CONTRAINDICATION identifies situations or actions that
may have an effect on patient safety.
– A WARNING identifies situations or actions that may have an
effect on patient or user safety. To ignore a warning could
cause patient or user injury.
– A CAUTION identifies special procedures or precautions that
persons must obey to help prevent equipment damage.
PRODUCT SYMBOLS
The following symbols may or may not be used on your Synclara™ Cough
System:
Symbol Definition
WARNING or CAUTION
The Synclara™ Cough System, Model PSC1
conforms to the European Medical Device
Directive 93/42/EEC <Pending info from C&S>
<Pending info from C&S>
Follow the operating instructions
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Synclara™ Cough System, Model PSC1 User Manual (196286 REV E) 5
Symbols and Acronyms
Rating for ingress protection in accordance with
IEC 60259
Unique Device Identification information
Type B equipment with an F-type applied part,
according to EN 60601-1
Class II equipment (double insulated), according to
EN60601-1
Manufacturer or distributor complies with the
Waste Electric and Electronic Equipment Directive
2002/96/EC
Manufacture date
Manufacturer
Serial number
Identifies a replaceable fuse link in an electronic
circuit
Catalog number
Non sterile
Symbol Definition
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6 Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)
Symbols and Acronyms
Single patient use
Physician prescription required (for US only)
Safe Working Load—this includes weight of
control unit and accessories such as patient
circuits
Mass of the medical equipment
Mass of the medical equipment including the
mass of the control unit, accessories, patient
circuits, and the pole clamp assembly
Warning—Read the User Manual for safety
information for the battery
Physician prescription required. This system is
certified for use on aircrafts. Complies with
RTCA/DO-160G Section 21 Category M
Foot switch port (Available only on custom-
configured systems.)
USB port
Power On/Off control
Symbol Definition
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Synclara™ Cough System, Model PSC1 User Manual (196286 REV E) 7
Symbols and Acronyms
COMMON SCREEN SYMBOLS
The following symbols may or may not be shown on the touchscreen.
Symbol Description
The system is connected to the AC power and not
powered by the battery.
The system is powered by the battery.
The system is connected to a WiFi network.
The system is transmitting data to the connected
WiFi network.
The system is connected to a cellular network.
A Bluetooth® device is connected to the system.
A USB drive is connected to the system.
A foot switch is connected to the system and can
be used to control Synclara™ therapy.
Clinical Access is enabled. The user is able to
access all features on the system.
Clinical Access is disabled. Some features are not
available to the user.
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8 Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)
Symbols and Acronyms
ACRONYMS
Heart rate of the patient.
Blood oxygen saturation level of the patient.
Strength of the cough flow.
Tidal volume delivered to the patient during the
therapy.
Acronym Meaning
HPP Highest Programed Pressure
PC Pressure Ceiling
PAP Positive Airway Pressure
PCF Peak Cough Flow
SpO2 Blood Oxygen Saturation
Vt Tidal Volume
Symbol Description
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Synclara™ Cough System, Model PSC1 User Manual (196286 REV E) 9
Safety Instructions
SAFETY INSTRUCTIONS
When using electrical products, especially when children are present,
basic safety precautions should always be followed, including the
following important safeguards.
READ ALL INSTRUCTIONS
BEFORE USING
Training shall be provided by a Hill-Rom qualified trainer or respiratory
therapist before the user uses the system for therapy delivery.
WARNING:
Obey all warnings throughout the manual and also those below to
help prevent injury and/or equipment damage:
•Warning—Only facility-authorized persons should open and
service this system.
•Warning—Federal USA law restricts this product to sale by or on
the order of a physician. Sale by or on the order of unauthorized
persons can cause patient injury.
•Warning—We recommend your first use of this product be in a
supervised setting such as a doctor’s office or at home with a
clinical trainer.
•Warning—This system should only be used by trained persons.
•Warning—Use this product only for its intended use as described
in this manual. Do not use attachments not recommended by the
manufacturer.
•Warning—Do not operate this system if it shows any signs of
physical damages, faulty conditions, or malfunction (e.g.
damaged power cord or plug, dropped, dropped in water, or if
the touchscreen does not operate).
•Warning—Do not use the system near to any heat source or
ignition source such as a fireplace or radiant heater.
•Warning—Never drop or insert any object into any opening or
hose.
•Warning—Adult supervision is required to use the therapy on
children.
•Warning—Close supervision throughout the treatment is
necessary when this product is used by children or patients with
physical limitations or impaired cognitive abilities.
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10 Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)
Safety Instructions
WARNING:
(Warnings continued) Obey all warnings throughout the manual and also
those below to help prevent injury and/or equipment damage:
•Warning—Make sure the position of the control unit is such that
you can quickly, without obstruction, disconnect the power cord
from the power outlet in the wall, if required.
•Warning—If it is necessary to disconnect/isolate the product
from the main power supply, disconnect the power cord plug
from the power inlet on the back of the control unit or disconnect
the power cord from the power outlet on the wall.
•Warning—No modification of this product is permitted.
•Warning—Do not operate the system under harsh conditions
(e.g. extreme temperature, excessive moisture, strong magnetic
fields). See Environmental Conditions for Use in “Specifications”
on page 90.
•Warning—Do not operate the system if fluid is spilled on the
control unit.
•Warning—Do not use the system near flammable chemicals or
products, including flammable anesthetics.
•Warning—Keep the hoses, tubings, and power cord away from
toddlers and children to avoid strangulation.
•Warning—Keep the small parts provided with this product away
from children to avoid swallowing and causing a choking effect.
•Warning—Do not connect any equipment or accessories to the
USB port on the system, except for Hill-Rom approved
accessories (See “Accessories”on page 59). The USB port on the
back of the system is only for retrieving information as described
in this user manual.
•Warning—Use only Hill-Rom authorized air hoses and
accessories to avoid allergic skin reactions.
•Warning—Do not store or use the system around pets, pests, or
unsupervised children.
•Warning—Keep the unit, battery, AC/DC power adapter, and
power cord away from heated surfaces.
•Warning—Remove the rechargeable battery from the control
unit if the control unit is not going to be used for an extended
period of time.
•Warning—Before cleaning, unplug the system from its power
source and remove the battery.
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Synclara™ Cough System, Model PSC1 User Manual (196286 REV E) 11
Safety Instructions
WARNING:
(Warnings continued) Obey all warnings throughout the manual and also
those below to help prevent injury and/or equipment damage:
•Warning—Do not allow any metallic conductive objects to
contact the battery terminals. Do not short circuit a battery or
throw it into the fire; it can explode and cause severe personal
injury.
•Warning—Improper battery use may result in a fire, explosion, or
other hazard.
•Warning—Do not use this system without a bio-filter.
•Warning—Do not use the system in a dusty environment.
•Warning—This product contains chemicals known to the State of
California to cause cancer and birth defects or other reproductive
harm.
•Warning—The Synclara™ Cough System is MR Unsafe. Do not
expose the system to any magnetic resonance (MR) environment.
NOTES:
• The system may present a risk of projectile injury due to the
presence of ferromagnetic materials that can be attracted by
the MR magnet core.
• The system may not function properly due to the strong
magnetic and radio frequency fields generated by the MR
equipment.
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12 Synclara™ Cough System, Model PSC1 User Manual (196286 REV E)
Safety Instructions
CAUTION:
Obey all cautions throughout the manual and also those below to help
prevent equipment damage:
•Caution—Read the User Manual before use.
•Caution—Do not block the air openings of the system or place it
on a soft surface, such as a bed or couch, where the air openings
may be blocked. Keep the air openings free of lint, hair, and the
like.
•Caution—If there is an ingress of liquids through the case or as a
result of not using a bio-filter, return the system for factory
service.
•Caution—Use only parts and accessories from Hill-Rom. Do not
use any unauthorized parts or accessories with this product.
•Caution—Use the Synclara™ Cough System only with the Hill-
Rom approved pulse oximeter (196694). The data from the pulse
oximeter is for information purposes only.
•Caution—Use the Synclara™ Cough System only with the Hill-
Rom approved replaceable battery (194566S).
•Caution—Do not open, crush, puncture, or incinerate the
battery. Do not immerse the replaceable battery in water, or heat
it over 140°F (60°C).
NOTE:
Caution—If the replaceable battery is used, fully charge the battery to
100% before first time use. Allow up to 8 hours for the initial full battery
charge to take place.For product assistance or to report issues with the
Synclara™ Cough System, Model PSC1, contact Hill-Rom:
• In the USA, call Hill-Rom at 800-426-4224.
• Outside of the USA, contact your distributor or local Hill-Rom
representative, or go to www.respiratorycare.hill-rom.com.
SAVE THESE INSTRUCTIONS
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