Hillrom Volara PVL1 User manual

Volara™ System
Model PVL1
User Manual
Product No. PVL1
Rx only: Federal USA law restricts this device to sale by or on the order of a
physician.
196654 REV C
196654__C_2019-Apr-29_Cleaned

196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196654 REV C) i
REVISION
© 2019 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED.
PATENTS / PATENT www.hill-rom.com/patents
The Volara™ System, Model PVL1 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 (196654) 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 C, 2019-04
Manufactured by:
HILL-ROM SERVICES PRIVATE LIMITED
1 YISHUN AVENUE 7
SINGAPORE 768923
196654__C_2019-Apr-29_Cleaned

ii Volara™ System, Model PVL1 User Manual (196654 REV C)
First Printing, 2019
Bluetooth® is a registered trademark of Bluetooth Sig, Inc.
Hill-Rom® is a registered trademark of Hill-Rom Services, Inc.
Volara™ is a trademark of Hill-Rom Services PTE Ltd.
Replace this manual (196654) if it is damaged and/or can not be read.
For product support or to order additional copies of this manual (196654),
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)
196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196654 REV C) iii
Table of Contents
Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
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
Volara™ Single Patient Use Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Assemble and Connect the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . 16
Connect the Volara™ Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Connect the Volara™ Patient Circuit for In-line Ventilation
Therapy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Assemble the Nebulizer Kit and Add Medication . . . . . . . . . 22
Set up and Power on the Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Power off the Control Unit and Store the System. . . . . . . . . . . . . . . . . . 25
Volara™ Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
About the Home Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
About the Options Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Start a Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Volara™ Therapy in Automatic Mode . . . . . . . . . . . . . . . . . . . . . . . . . 30
Basic View in Automatic Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . 30
196654__C_2019-Apr-29_Cleaned

iv Volara™ System, Model PVL1 User Manual (196654 REV C)
Table of Contents
Start a Therapy in Automatic Mode . . . . . . . . . . . . . . . . . . . . . . 31
Adjust Cough Pause Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Access the Advanced View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Volara™ Therapy in Manual Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Basic View in Manual Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Start a Therapy in Manual Mode . . . . . . . . . . . . . . . . . . . . . . . . . 35
Advanced Volara™ Therapy Settings . . . . . . . . . . . . . . . . . . . . . . . . . 38
Modify a Preset Therapy Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Rename a Preset Therapy Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Delete a Preset Therapy Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Volara™ Therapy with an In-line Ventilator . . . . . . . . . . . . . . . . . . . 45
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Device Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Adjust Screen Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Adjust Date and Time settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Change the System Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Enable or Disable Clinical Access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Set the Pressure Ceiling Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Connect a Barcode Reader or Pulse Oximeter . . . . . . . . . . . . . . . . 51
Connect to a WIFI Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Connect to a Local WIFI Network . . . . . . . . . . . . . . . . . . . . . . . . 52
Connect to a Public Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Connect to an Enterprise Network . . . . . . . . . . . . . . . . . . . . . . . 55
Configure Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Test the Connection to VisiView™ Health portal . . . . . . . . . . 58
Test the Connection to Electronic Medical Records (EMR). 59
Retrieve Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Retrieve the Therapy Logs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Retrieve the Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Import and Export Device Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . 63
View the Firmware Version and System Information . . . . . . . . . . 64
Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Replaceable Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Install the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196654 REV C) v
Table of Contents
Charge the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Mobile Stand and Pole Clamp Assembly . . . . . . . . . . . . . . . . . . . . . . 71
Install the Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Install the Tray and Pole Clamp . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Install the Control Unit on the Cart and Stand Assembly . . 74
Move the Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Install the Control Unit on a Medical Rail or IV pole . . . . . . . 76
Replacement Parts/Kits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Clean the Control Unit and Stand with Cart . . . . . . . . . . . . . . . . . . . 80
Clean the Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Clean the Single Patient Use Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Disinfect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Inlet Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Nebulizer Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Expected Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Service calls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Control Unit Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
On-screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Information Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Audio Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Notification Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Warning Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Caution Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Shipping and Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Shipping for Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Product Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
196654__C_2019-Apr-29_Cleaned

vi Volara™ System, Model PVL1 User Manual (196654 REV C)
Table of Contents
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Replaceable Battery (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Environmental Conditions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Environmental Conditions for Transport and Storage. . . . . . . . . 97
System Cool Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Wireless Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Classification and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Federal Communications Commission (FCC) Compliance
Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Electromagnetic Compatibility Guidance . . . . . . . . . . . . . . . . . . . 102
Electromagnetic Immunity to Wireless Communications . . . . 106
196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196286 REV C) 1
Intended Use
INTENDED USE
The Volara™ System, Model PVL1 is intended for the mobilization of
secretions, lung expansion therapy, the treatment and prevention of
pulmonary atelectasis, and has the ability to provide supplemental
oxygen when used with oxygen supply.
INTENDED PATIENT POPULATION
The Volara™ System is intended to deliver therapy to adults and children
over the age of 2.
INTRODUCTION
This manual includes instructions for setup, use, and maintenance of the
Volara™ System, Model PVL1. 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 Volara™ System:
• Theory of operation (See page 2)
• Indications for Use (See page 2)
• Contraindications (See page 2)
It is important that you read and understand the information in this
section before you use the system.
196654__C_2019-Apr-29_Cleaned

2 Volara™ System, Model PVL1 User Manual (196286 REV C)
Important Information
THEORY OF OPERATION
The Volara™ System provides a therapy that enhances secretion removal
and helps prevent or resolve patchy atelectasis.
The system delivers therapy in two modes:
•CHFO (Continuous High Frequency Oscillation)—a pneumatic
form of chest physiotherapy that delivers medicated aerosol while
oscillating the airways with continuous pulses of positive pressure.
•CPEP (Continuous Positive Expiratory Pressure)—supplies
continuous positive pressure to help hold open and expand the
airways.
With both therapy, the system can also deliver aerosolized medications
and supplemental oxygen. The nebulizer kit of the Volara™ patient circuit
is designed to aerosolize medication approved for nebulization and
prescribed by a physician.
INDICATIONS FOR USE
The Volara™ System is indicated for, but is not limited to patients with
these conditions:
• Difficulty in clearance of secretions
• Pulmonary atelectasis
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 Volara™ System is contraindicated if this patient condition exists:
• Untreated tension pneumothorax
196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196286 REV C) 3
Important Information
RELATIVE CONTRAINDICATIONS
When you use the Volara™ System, patients with these conditions should
be carefully evaluated before a decision is made to use the therapy:
• History of pneumothorax
• Pulmonary air leak
• Recent pneumonectomy
• Pulmonary hemorrhage
• Myocardial infarction
• Vomiting
POSSIBLE ADVERSE CONDITIONS
When using the Volara™ System, patients may experience one or more of
these effects:
• Hyperventilation
• Gastric distension
• Decreased cardiac output
• Increased intracranial pressure
• Increased air trapping
• Hyperoxygenation
• Pneumothorax
• Pulmonary air leak
• Pulmonary hemorrhage
196654__C_2019-Apr-29_Cleaned

4 Volara™ System, Model PVL1 User Manual (196286 REV C)
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 Volara™ System:
Symbol Definition
WARNING or CAUTION
The Volara™ System, Model PVL1 conforms to the
European Medical Device Directive 93/42/EEC
<Pending info from C&S>
<Pending info from C&S>
Follow the operating instructions
196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196286 REV C) 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
196654__C_2019-Apr-29_Cleaned

6 Volara™ System, Model PVL1 User Manual (196286 REV C)
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
Nebulizer port
USB port
Power On/Off control
Symbol Definition
196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196286 REV C) 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.
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.
Heart rate of the patient.
196654__C_2019-Apr-29_Cleaned

8 Volara™ System, Model PVL1 User Manual (196286 REV C)
Symbols and Acronyms
ACRONYMS
Blood oxygen saturation level of the patient.
Strength of the cough flow.
Tidal volume delivered to the patient during the
therapy.
Acronym Meaning
CHFO Continuous High Frequency Oscillation
CPEP Continuous Positive Expiratory Pressure
HPP Highest Programed Pressure
PC Pressure Ceiling
PCF Peak Cough Flow
SpO2 Blood Oxygen Saturation
Vt Tidal Volume
Symbol Description
196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196286 REV C) 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.
196654__C_2019-Apr-29_Cleaned

10 Volara™ System, Model PVL1 User Manual (196286 REV C)
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 96.
•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 65). 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.
196654__C_2019-Apr-29_Cleaned

Volara™ System, Model PVL1 User Manual (196286 REV C) 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—Use only the supplied nebulizer kit in the patient
circuit.
•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 Volara™ 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.
196654__C_2019-Apr-29_Cleaned

12 Volara™ System, Model PVL1 User Manual (196286 REV C)
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 Volara™ System only with the Hill-Rom
approved pulse oximeter (196694). The data from the pulse
oximeter is for information purposes only.
•Caution—Use the Volara™ 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
Volara™ System, Model PVL1, 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
196654__C_2019-Apr-29_Cleaned