Breathe NIOV User manual

THE BREATHE NIOV
TM
VENTILATION SYSTEM
PATIENT Instructions for Use
Breathe Technologies, Inc.
175 Technology Drive, Suite 100
Irvine, CA 92618 USA
1-877-698-1325
[email protected]
www.breathetechnologies.com
Technical Support and Customer Service
United States: 1-877-698-1326
www.BreatheNIOV.com
PL-50-0037-E ©2012. NIOV is a trademark of Breathe Technologies, Inc.

ii
i
This manual provides detailed information
about the Breathe Non-Invasive Open
Ventilation (NIOV) System and step-by-step
instructions for using its features.
Chapter 1: Introduction includes critical
information that must be read before using
the system:
Indications for Use outlines who
can typically benefit from using the
ventilation system.
Safety Information lists precautions
that must be taken to ensure safe
operation of the ventilation system.
Chapter 2: System Overview gives an
overview of the ventilation system’s
features.
Chapter 3: Using the Ventilation System
describes the six basic tasks that you will
perform when using the system:
• Checkthebatterycharge.
• Connectandturnonanoxygensupply.
• ConnectandweartheBreatheNIOV
Pillows Interface.
• Attachtheventilator.
• Turnontheventilatorandchoosean
activity setting.
• Adjustthetriggersensitivity.
Chapter 4: Alarms and Troubleshooting
describes how alarms are displayed and
gives information on what triggers them
and how to clear them.
Chapter 5: Setup and Care describes
procedures for defining ventilator system
settings and for caring for the system.
Chapter 6: Icons provides a reference chart
for the symbols used.
Symbols and Conventions
To make it easier to find information you
need and alert you to potential hazards, the
following symbols and conventions are used
throughout this manual:
This Means this
WARNING: Indicates hazards that,
if not avoided, may cause severe
injuryordeath.
CAUTION: Indicates hazards that,
if not avoided, may result in minor
ormoderateinjury,ordamage
to or impaired performance of
equipment.
TIP: Indicates tips or additional
information that may be helpful
when using the ventilation
system.
The names of menu items and buttons
displayed on the ventilator touch screen are
indicated with bold text. For example, the
Menu screen has several buttons, including
Home Screen, Settings, and Information.
WELCOME
WARRANTY
Breathe Technologies, Inc. warrants that the Breathe Non-Invasive Open Ventilator (NIOV™)
is free from defects in material and workmanship for a period of one (1) year from the date of
shipment.
Patient interface, accessories and other associated parts are warranted for ninety (90) days from
date of shipment.
Breathe Technologies, Inc. will, at its option, either repair, replace, or issue credit for products that
prove to be defective during the warranty period.
For warranty service or repair, the product must be returned to Breathe Technologies, Inc. or a
service facility designated by Breathe Technologies, Inc. shipping prepaid by the Buyer.
LIMITATION OF WARRANTY
Ordinary maintenance, as specified in this Instructions for Use and the Service Manual, is not
covered under the forgoing warranty.
The forgoing warranty does not apply to defects resulting from:
1. Improper or inadequate maintenance of the unit.
2. Improper use or misuse of the unit.
3. Unauthorized modifications or repairs to the unit.
4. Useoftheunitwithunauthorizedaccessories,e.g,externalbatteryorACadapter.
5. Operation of the unit outside the specified environment.
NO IMPLIED WARRANTIES
This warranty is exclusive. There are no other warranties expressed or implied.
LIMITATION OF LIABILITY
Breathe Technologies, Inc. shall not be liable for loss of profits, loss of use, consequential
damages, or any other claim based on breach of warranty. Breathe Technologies, Inc.’s liability for
damages of any kind shall be limited to the purchase price of the defective unit.
PRODUCT WARRANTY

iv
iii
The information contained in this document is of a proprietary and confidential nature and
is intended only for the persons to whom it is directly transmitted by Breathe Technologies,
Inc. No part of this manual may be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying and recording, for any purpose without the
express written permission of Breathe Technologies, Inc.
This document corresponds to the version/revision level effective at the time of delivery.
Revisions to documentation are not automatically distributed. Please contact Breathe
Technologies to order current revisions.
NIOV™ and Breathe. Move. Live.™ are trademarks of Breathe Technologies, Inc. For applicable
US and Foreign Patent Coverage, see www.breathetechnologies.com/patents. All other products
or services mentioned in this manual are identified by the trademark or service marks of their
respective companies or organizations. Breathe Technologies, Inc. disclaims any responsibility
for specifying which marks are owned by which companies or organizations.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
The Breathe NIOV Ventilator contains electrical components that must be disposed of
according to the guidelines of the WEEE Directive (Waste in Electrical and Electronic
Equipment), Directive 2002/96/EC. Follow local regulations when disposing the
ventilator.
Breathe NIOV Ventilation System
Patient Instructions for Use
Copyright © 2012 by Breathe Technologies, Inc.
All Rights Reserved
Technical Support and Customer Service
United States: 1-877-698-1326
Chapter 1: Introduction ________________1
Indications for Use ______________________2
Patient Participation _____________________2
Safety Information ______________________3
Chapter 2: System Overview ___________4
VentilationSystemComponents __________5
Breathe Pillows Interface ________________6
Ventilator Features ______________________6
Turning the Ventilator On and Off _________ 8
Touch Screen Features __________________ 9
Touch Screen Energy-Save Mode ________10
Chapter 3: Using the Ventilation
System ______________________________11
Step1.ChecktheBatteryCharge________12
Step2.ConnectandTurnonan
Oxygen Supply ________________________13
Step3.ConnectandWearthe
Pillows Interface_______________________16
Step4.AttachtheVentilator_____________19
Step 5. Turn On the Ventilator and
ChooseanActivitySetting ______________19
Step6.AdjusttheTriggerSensitivity _____20
Chapter 4: Alarms and Troubleshooting 22
AudioAlarmSounds ___________________23
AlarmMessageDisplay_________________23
ActiveAlarmsWindow _________________24
SilencingandClearingAlarmsSummary __25
NIOVVentilationSystemAlarms _________26
AdditionalTroubleshootingSituations_____28
Chapter 5: Setup and Care_____________31
ChangingVentilatorSettings ____________32
SettingTimeandDate __________________33
Setting Vibration Mode _________________34
SettingAudioLoudness ________________35
AdjustingScreenBrightness ____________36
Viewing Software Version Information ____37
CaringfortheNIOVVentilationSystem ___37
Battery Retraining and Replacement _____41
Oxygen Supply Information _____________41
Chapter 6: Icons ______________________43
Index ________________________________47
CONTENTS

2
1
CHAPTER
INTRODUCTION
This section includes the critical information that must be read
before using the system.
Indications for Use
ClinicalConsiderationsforUse
Patient Participation
Safety Information
INDICATIONS FOR USE
The NIOV Ventilator, with accessories, is
a volume assist ventilator intended to aid
adult patients with respiratory insufficiency.
It is designed for patients that are capable
of spontaneously breathing a minimum
tidal volume of 3.5 ml/kg of predicted
body weight. The device is designed for
continuous applications such as patient
ambulation, physical therapy, occupational
therapy, respiratory therapy, and other
rehabilitation efforts in an institutional or
home care environment. The device is
intended for operation by trained personnel,
patients or their caregivers under the
direction of a physician.
PATIENT PARTICIPATION
The use of the NIOV Ventilation System
requires moderate patient participation,
and therefore the patient must be able to
understand and comply with instructions.
WARNING: Use the NIOV Ventilation
System only for patients who meet the
indications for use. If the ventilation
system is used for patients that do not meet
the ventilation system indications for use,
patients may not receive appropriate respiratory
therapy.

3
SYSTEM OVERVIEW
This section describes the basic parts and functions of the
NIOV Ventilation System.
Ventilation System Components
Breathe Pillows Interface
Ventilator Features
Turning the Ventilator On and Off
Touch Screen Features
Touch Screen Energy-Save Mode
2
CHAPTER
1INTRODUCTION
SAFETY INFORMATION
Before using the NIOV Ventilation System,
you must be appropriately trained and must
fully understand potential safety hazards.
Read the following safety warnings and
cautions in their entirety before using the
ventilationsystem.Additionalwarnings
and cautions can be found throughout this
manual.
WARNING: The NIOV Ventilation
System is not designed for patients
who cannot spontaneously breathe or
who are fully dependent on mechanical
ventilation.
Failure to read the manual may result in
product misuse, which may cause equipment
damage or patient mistreatment.
If the NIOV Ventilation System is not
functioning correctly, you may not receive
appropriate respiratory therapy. Always have an
alternate means of oxygen therapy available.
Do not allow smoking near oxygen sources or
near the ventilator and do not place oxygen
sources or the ventilator near any source of
direct heat because flammable materials burn
more readily in the presence of oxygen.
If the NIOV Ventilation System is not
functioning correctly, use your standard
oxygen therapy and contact your health
care provider.
CAUTION: Do not use the NIOV
Ventilation System in magnetic
resonance imaging (MRI) environments.
MRI equipment may cause electronic
components in the ventilator to malfunction.
Do not submerge the ventilator in liquids
or pour liquids on it. Liquids may cause
components in the ventilator to malfunction.
Do not eat, drink, or chew gum while using the
ventilator. Food or liquids that make contact
with the ventilator may cause components in
the ventilator to malfunction. Eating, drinking,
or chewing gum may also increase the risk of
choking.
When the ventilator is in use, keep it in a
well-ventilated area to prevent it from
overheating. The ventilator may overheat
and be permanently damaged if it is used
in an area that is not well ventilated.

6
5
2SyStem Overview
BREATHE PILLOWS
INTERFACE
The Breathe Pillows Interface for use
with the ventilator is not included with
the ventilation system components and is
shipped separately. For instructions on how
tot,adjust,andconnecttheinterface,see
the section Using the NIOV Ventilation
System in this manual and refer to the
Breathe Pillows Interface Quick Start guide
included with each interface.
WARNING: Use the NIOV Ventilation
System only with the Pillows Interface.
If the ventilation system is used with
another manufacturer’s interface, the ventilator
may not function correctly and you may not
receive appropriate respiratory therapy.
CAUTION: Use a Pillows Interface for a
maximum of 30 days. If an interface is
used for more than 30 days, its
performance may degrade and you may not
receive adequate respiratory therapy.
Do not use a Pillows Interface that is cracked,
odorous, broken, or kinked. If a damaged
interface is used, you may not receive adequate
respiratory therapy.
VENTILATOR FEATURES
The following illustrations identify the
ventilator buttons and connections.
1Touch screen
2Activity buttons
3Power button
4Power light
5Speaker
6Backup alarm buzzer
7Breath indicator light
VENTILATION SYSTEM COMPONENTS
The NIOV Ventilation System is an ultra-lightweight, wearable, system designed to improve
breathing by providing increased ventilation to adult respiratory patients when they need it. Because
of the system’s portability, patients have greater mobility and can move about freely and easily.
The NIOV Ventilation System consists of the ventilator, Breathe Pillows Interface, oxygen hose,
battery charger, purge tube, and belt clip. The ventilation system is intended for use by patients
in the home or institutional setting.
Note: The ventilation system does not include an oxygen cylinder. Shipping configurations may vary
based on order.
TIP: The ventilator is shipped in a specially designed, protective box. Do not throw away the box.
Keep it for future transportation needs.
1Purge tube
2Oxygen cylinder
(not included)
3Oxygen regulator
4Oxygen supply
hose
5Ventilator
6Belt clip
7Pillows
Interface
(shipped
separately)
8Battery
charger

8
7
2SyStem Overview
TURNING THE VENTILATOR
ON AND OFF
1Power button
• Toturntheventilatoron,pressthePower
button.
• Toturntheventilatoroff,pressthePower
button for approximately three seconds.
Turn On Sequence
Whenyouturnontheventilator,thegreen
power light is illuminated. The ventilator
performsaselftest.Duringthetest,all
indicator lights should briefly flash and an
audible alarm should briefly sound. This self
test can take up to 15 seconds to complete.
If you do not hear an audible alarm when you
turn on the ventilator, contact your health
care provider.
1Green power light is on.
2Test screen is displayed. (The software
version in this screen is for illustration
purposes only.)
3Home screen is displayed without data.
4 WhentheHome screen is displayed, the
touch screen is ready to use.
Activity and Power Buttons
Low Activity button
Medium Activity button
High Activity button
Power button
WARNING: Do not cover the ventilator
speaker or backup alarm buzzer with
tape or any other object. Covering the
ventilator speaker or buzzer may make it
difficult for a patient to hear alarms, which
may result in inadequate respiratory therapy.
Top End of Ventilator
1Battery charger connection
2Alarm Silence button
3Not used
Bottom End of Ventilator
1Interface port
2Oxygen supply connection

10
9
2SyStem Overview
Menu Screen
Use the Menu screen to go to the Settings
menu, get information about the software
version of the ventilator and ventilator use, or
go back to the Home screen.
To get to the Menu screen, on any ventilator
screen, touch the Wrench button.
1 Screen title.
2Touch to go to the Home screen.
3Touch to go to the Settings screen for
Trigger Sensitivity, and Utilities.
4Touch to go to the Software Version
screen for software version and total use
time.
Moving Between the Home Screen and
Menu Screen
1Touch the Wrench button to go to the
Menu screen.
2Touch the Home Screen button to go to
the Home screen.
TOUCH SCREEN FEATURES
The NIOV Ventilation System uses a
touch screen for setting up the ventilator,
monitoring patient data, and displaying alarm
information. To use the touch screen, simply
touch a screen button or an area of the
screenyouwanttomakeactive.Anaudible
“click” indicates the feature you touch is
activated.
There are two main ventilator screens: the
Home screen and the Menu screen.
Home Screen
Whenyouturnontheventilator,afterit
completes a self test, the touch screen
displays the Homescreen.Aftertheoxygen
supply is connected and the patient is
wearing the Pillows Interface, when you
press a ventilator Activity button, the Home
screen displays patient oxygen flow rate and
breath rate.
The following illustration shows the buttons,
icons, and information displayed on the
Home screen.
1Touch the Wrench button to go to the
Menu screen.
2 CurrentActivity icon and augmentation
volume.
3Touch the Flip button to flip the screen
180°.
4 Currentbreathsperminute(BPM).
5 Averageoxygenowinlitersperminute,
based on activity setting and patient’s
current breath rate.
6Battery Charge icon.
7 CurrentActivity icon. Use the ventilator
Activity buttons to change an activity
setting.
8Vibration icon indicating ventilator is in
vibration mode.
9Time and date display.
Note: The Wrench and Flip buttons at the top
of the screen and the time and date, current
Activity icon, and Battery Charge icon at the
bottom are displayed on all screens.
TOUCH SCREEN ENERGY-SAVE MODE
Aftertwominuteswithnouserinteraction,thetouchscreenautomaticallyentersenergy-save
mode and dims the screen. Touching the screen again will reactivate it and display the Home
screen.

12
3
CHAPTER
USING THE
VENTILATION SYSTEM
This section describes the six basic steps you need to perform to
set up and use the NIOV Ventilation System.
Step1.ChecktheBatteryCharge
Step2.ConnectandTurnonanOxygenSupply
Step3.ConnectandWearthePillowsInterface
Step4.AttachtheVentilator
Step5.TurnOntheVentilatorandChooseanActivitySetting
Step6.AdjusttheTriggerSensitivity
STEP 1: CHECK THE
BATTERY CHARGE
Before you use the ventilator, check that the
battery is fully charged.
1Press the Power button to turn on the
ventilator.
2 CheckthatthefullychargedBattery
Charge icon is displayed before using the
ventilation system.
It takes approximately three hours to fully
recharge the battery when the ventilator’s
poweristurnedoff,.Afullychargedbattery
should last approximately four hours.
The Battery Charge icon appears on every
touch screen.
This icon Means this
Charging
~Fully charged
~¾ charged
~½ charged
~¼ charged
Less than
1/6
Empty battery, no charge,
or status unknown
Assemble the Battery Charger and
Charge the Battery
If the ventilator is off, the battery charger
light turns green when the battery is fully
charged. The ventilator can be on and in use
while the battery is charging, but the battery
chargerlightwillremainred.Althoughthe
ventilator can be charged while in use, it is
recommended that the ventilator is charged
with the power off to ensure a full charge.
ChecktheBatteryChargeicononthetouch
screen to see the current battery charge
level.

14
13
3Using the Ventilation system
1 Connectthebatterychargercordtothe
ventilator charger port. The word UP on
the battery charger cord will be facing
the front of the ventilator.
2Plug the power cord of the battery
charger assembly into the battery charger.
3Plug in the wall plug.
Note: the ventilator can be used while the
battery is charging.
CAUTION: Do not place the battery
charger on wet surfaces or use in wet
environments. Wet environments may
damage the battery charger and may cause
electric shock.
CAUTION: Use only the Breathe
Technologies approved battery charger
and cord set with the ventilator. If an
unauthorized battery charger or cord set is used
with the ventilator, the ventilator may be
damaged.
STEP 2: CONNECT AND
TURN ON AN OXYGEN
SUPPLY
This section gives instructions on connecting
the oxygen regulator and ventilator to an
oxygen cylinder, turning the oxygen supply
on and off, and replacing an oxygen cylinder.
WARNING: If the NIOV Ventilation
System is not used with a regulator
capable of 41–87 psig (nominal 50
psig) with greater than 28 LPM capability, you
may not receive appropriate respiratory therapy.
CAUTION: Use only a Breathe
Technologies approved O2supply hose
with the ventilator. If an unauthorized
O2supply hose is used with the ventilator, the
ventilator may be damaged.
TIP: Use a regulator to regulate the
pressure to 41–87 psig (50 psig
nominal) before attaching oxygen to
the ventilator. Refer to the regulator and
oxygen supply manufacturers’ instructions.
TIP: The oxygen supply hose should
remain connected to the ventilator at
all times, except when required to be
disconnected for maintenance, testing, or
replacement. If it is disconnected while the
ventilator is on and a therapy level active, an
alarm occurs. If this happens, turn the
ventilator off, and reconnect the hose.
Connecting the Regulator to an
Oxygen Cylinder
1Slide the regulator over the neck of the
cylinder, and line up the pins on the
regulator with the holes in the cylinder
neck.
2Tighten the tee screw on the regulator by
turning the handle clockwise.
3Ensure the barbed outlet airflow gauge is
set to 0.
Connecting the Ventilator to an
Oxygen Cylinder
1Turn the ventilator off by firmly pressing
the Power button for about three
seconds.

16
15
3Using the Ventilation system
2Push the small oxygen supply hose
connector onto the oxygen supply
connection until it snaps into place.
3 Connectthegreenoxygensupplyhose
connector to the oxygen regulator by
turning it clockwise.
4 Withtheventilatorpoweroffand
the oxygen supply hose connected
to the ventilator and oxygen supply,
follow the regulator and oxygen supply
manufacturers’ instructions for turning on
the oxygen supply.
Replacing an Oxygen Cylinder
Whenanoxygencylinderneedstobe
replaced:
1Turn the ventilator off by firmly pressing
the Power button for at least three
seconds.
2Follow the oxygen and regulator
manufacturers’ instructions for shutting
off the oxygen supply.
3 Disconnecttheventilatoroxygensupply
hose from the oxygen supply.
4 Connecttheventilatoroxygensupply
hose to a new oxygen cylinder.
5Follow the oxygen and regulator
manufacturers’ instructions for turning
on the oxygen cylinder.
1Tubetadjustor
2Ventilator connector
3Interface tubing
4Interface pillows
Connecting the Interface to the
Ventilator
1Turn off the ventilator.
2Plug the interface into the ventilator port.
STEP 3: CONNECT AND WEAR THE PILLOWS INTERFACE
Before using the Pillows Interface, visually inspect it for damage.
The interface comes in four sizes: extra small, small, medium, and large. Your health care provider
determines what size is best for you. The interface assembly is packaged clean but not sterile.

18
17
3Using the Ventilation system
Wearing the Interface
1Place the interface in front of you with the
arrows underneath pointing up and the
curve of the interface towards you.
2Loop the interface tubing over the ears so
the pillows of the interface are positioned
snugly inside the nostrils. For proper
positioning of the interface, see the
next section in this Step: Checking the
Interface Positioning.
3 Adjustthetubinglengthunderthechinso
that the interface is comfortably secured.
Checking the Interface Positioning
The interface is placed correctly if the
following conditions are met:
• Theinterfacepillowsrestsnuglyinside
the nostrils, as shown.
• Thetiscomfortable.
• Theinterfacedoesnotmakebreathing
difficult.
• Airdoesnotowtotheeyes,cheeks,or
lips.
If any one of these conditions is not met,
reposition the interface. If problems persist,
contact your health care provider.
TIP: When the interface is in use,
periodically check that it is positioned
correctly and make adjustments as
required. If skin becomes irritated, stop using
the device, and contact your health care
provider.

20
19
3Using the Ventilation system
STEP 4: ATTACH THE
VENTILATOR
You can attach the ventilator to a belt or
waistband. Instructions here describe how
to use the belt clip to attach the ventilator to
a belt or waist band. The ventilator can be
worn on either the right or left side.
1Position the clip over the belt, and push
down until it is secure.
2Line up the belt clip with the ventilator
sockets, and push down until the clip
audibly snaps into place.
CAUTION: Make sure the clip is
securely fastened to the belt and the
ventilator. If the clip is not securely
fastened to the belt or the ventilator, the
ventilator may drop and be damaged.
STEP 5: TURN ON THE
VENTILATOR AND CHOOSE
AN ACTIVITY SETTING
Whenyourstturnontheventilator,no
activity setting is active. The three Activity
buttons on the ventilator (Low Activity,
Medium Activity, High Activity) correspond
to three different augmentation volumes
prescribedbyaphysician.Choosean
Activity button appropriate for your level of
activity. You can change the level at any time.
1Turn on the ventilator.
2Press an Activity button for about one
second until you hear a tone that indicates
it is active.
3 ConrmtheselectedActivity icon
is displayed on the touch screen
(High Activity shown).
STEP 6: ADJUST THE
TRIGGER SENSITIVITY
Trigger sensitivity determines how easily
your breath triggers the ventilator to deliver
oxygen. For shallow breathing, set the trigger
sensitivity to a low number. You can choose
a setting between 0 and 9. Zero is the most
sensitive and 9 is the least sensitive setting.
Getting to the Trigger Sensitivity
Screen
1On any ventilator screen, touch the
Wrench button.

21
4
Chapter
ALARMS AND
TROUBLESHOOTING
This section describes the alarm functions and possible
troubleshooting solutions.
AudioAlarmSounds
AlarmMessageDisplay
ActiveAlarmsWindow
SilencingandClearingAlarmsSummary
NIOVVentilationSystemAlarms
AdditionalTroubleshootingSituations
3USING THE VENTILATION SYSTEM
2On the Menu screen, touch Settings.
3On the Settings Menu screen, touch
Trigger Sensitivity.
Changing Trigger Sensitivity
1On the Trigger Sensitivity screen, touch
the Up arrow to increase the value or
the Down arrow to decrease it. If you
press and hold an arrow, the number
automatically increases or decreases.
Note: The lower the number, the more
sensitive the setting.
2 Whenyouarenished,touchOK.
3In the message asking if the settings are
OK, touch Confirm.
Note:Changestosettingsonlytake
effect when you touch Confirm.

24
23
4AlArms And TroubleshooTing
ACTIVE ALARMS WINDOW
Multiple alarms may occur at the same time.
Touch the Active Alarms button at the top
of the touch screen to display a list of active
alarms.
1 Touch the Active Alarms button to
display the alarm list.
2 Alarm icon.
3 Scroll Down arrow.
4 Scroll Up arrow.
1 Alarmmessagealternatesbetweeneach
occurring alarm.
2Alarm Silenced icon.
3Alarm Silenced icon is displayed when
all alarms are silenced.
TIPS: The Active Alarms window
displays up to three alarms, from
highest to lowest priority (red, yellow,
blue). If there are more than three alarms, you
can use the Scroll Up and Scroll Down arrows to
scroll through the list.
Analarmindicatesaconditionthatneedsto
be identified and resolved. There are three
alarm priority levels: high, medium, and low.
This section describes alarm priority levels,
the alarm messages displayed at the top of
the touch screen, and the Active Alarms
window. The section also includes tables that
list the possible causes of an alarm and the
options for resolving it.
AUDIO ALARM SOUNDS
Each alarm priority level has a distinct sound,
described as follows:
Alarm Priority Levels and
Corresponding Sounds
Alarm priority: High-priority alarm
Sound: Sequence of two sets of five tones
Alarm priority: Medium-priority alarm
Sound: Sequence of three tones
Alarm priority: Low-priority alarm
Sound: Single tone
ALARM MESSAGE DISPLAY
Whenanaudiblealarmoccurs,analarm
message flashes at the top of the touch
screen. The priority level of an alarm is
indicated by the color and the rate at which
the message flashes.
Ared,rapidlyashingalarmmessageisa
high-priority alarm and indicates a situation
that requires immediate attention.
Ayellow,steadilyashingalarmmessage
is a medium-priority alarm and indicates a
potentially hazardous situation that must be
resolved in a timely manner.
Ablue,non-ashingalarmmessageisalow-
priority alarm and indicates a problem that is
not hazardous but should be resolved.

26
25
4AlArms And TroubleshooTing
SILENCING AND CLEARING
ALARMS SUMMARY
Silencing and clearing alarms is a multi-step
process that depends on alarm priority and
how many alarms are active.
1Silence Alarm button.
Press the Silence Alarm button to
temporarily silence the alarm for 60
seconds. Pressing the Silence Alarm
button silences only one alarm at a
time—in audible or vibrating alarm mode.
If more than one alarm occurs, press
the Silence Alarm button once for each
alarm. If the alarm is a medium- or high-
priority alarm and is not silenced after 60
seconds, the alarm will resume with an
additional buzzer.
2Resolve the condition that triggered the
alarm. For help resolving alarms, see the
alarm and troubleshooting tables that
follow for possible causes of an alarm and
options to resolve it. If an alarm silence
button is pressed but not resolved, the
alarm will sound again after 60 seconds.
3 Afterresolvingahigh-priorityalarm,touch
OK in the message that indicates the
alarm has been resolved.
Message indicating a high-priority alarm has
been resolved.
NIOV VENTILATION SYSTEM ALARMS
The following tables list high-, medium-, and low-priority alarms. For each alarm, the tables list the
screen message, the possible causes for the alarm, and the checks and options for resolving it.
High-Priority Alarms
Screen Alert Cause Checks and Possible Resolution
High
Temperature
CPUorbattery
temperature is
above the allowable
limit.
Checktomakesuretheventilatoris:
•Notnearaheatsource.
•Inawellventilatedarea.
•Notcoveredorenclosed.
High Circuit
Pressure
Interface may be
pinched or kinked.
Checktheinterfacetube.Replaceitifitispinchedor
kinked.
High PEEP
Pressure
Interface may be
blocked.
Inspect and clean the interface per the instruction
for cleaning the interface.
Medium-Priority Alarms
Screen Alert Cause Checks and Possible Resolution
Breath Timeout No breath is
detected for 20
or 60 seconds,
depending on the
setting.
•Patientisnotbreathingorbreathistooshallowto
trigger augmentation.
Note: The ventilator is not indicated for patients who
are not spontaneously breathing with a minimum
volume of 3.5 ml/kg.
•Inspectandcleantheinterfacepertheinstruction
for cleaning the interface.

28
27
4AlArms And TroubleshooTing
High Breath
Rate
Respiratory rate
exceeds the set
limit.
•Patientisbreathingfasterthantheratesetbya
clinician.
•Inspectandcleantheinterfacepertheinstruction
for cleaning the interface.
Screen Alert Cause Checks and Possible Resolution
High Del.
Pressure
Interface pressure
during delivery
exceeds the
maximum expected.
•Checktheinterface.Replaceitifthetubingistorn,
bent, or kinked.
•Makesurethetubingisnotpinchedorcrushed.
High Gas
Pressure
Source gas pressure
exceeds the
allowable limit.
•Usearegulatortoadjustthesourcegaspressure
to within the acceptable range of 41–87 psig (50
psig nominal).
Low Breath
Rate
Respiratory rate falls
below the set limit.
•Patient’sbreathingistooshallowtoconsistently
trigger augmentation.
•Inspectandcleantheinterfacepertheinstruction
for cleaning the interface.
•Patientisbreathingthroughthemouth.
Low Del.
Pressure
Interface pressure
during delivery
fails to exceed the
minimum expected.
•Checktheinterfaceconnectiontotheventilator.
•Checktheinterface.Replaceitifitisleaking.
•Checktheoxygeninputpressure.Ifitis<41psig,
usearegulatortoadjustitwithintheacceptable
range of 41–87 psig (50 psig nominal).
•Checktheoxygensupplytoventilatorconnections.
Low Gas
Pressure
Source gas pressure
drops below the
allowable limit.
•Checktheoxygensupplylevel.
•Checktheoxygensupplytoventilatorconnections.
•Checktheoxygensupplyregulator.
•Checkthattheoxygencylindervalveisfullyopen.
System Fault Internal fault
detected during
operation.
•Ifasystemfaultoccurs,inthemessagetoreboot
the ventilator, touch OK. Turn off the ventilator, and
turn it on again.
•Ifsystemfaultpersists,continuewithyour
prescribed backup therapy and contact your
health care provider.
Very Low Battery Currentbattery
capacity drops below
15%.
•Rechargethebattery.
•Ifthebatterydoesnotrecharge,contactyour
health care provider.
Low-Priority Alarms
Screen Alert Cause Checks and Possible Resolution
Battery Low Battery capacity
drops below 25%.
•Rechargethebattery.
•Ifthebatterydoesnotrecharge,contactyour
health care provider.
System Fault System fault
detected during
power on.
•Ifasystemfaultoccurs,inthemessagetoreboot
the ventilator, touch OK. Turn off the ventilator, and
turn it on again.
•Ifsystemfaultpersists,continuewithyour
prescribed backup therapy and contact your
health care provider.
ADDITIONAL TROUBLESHOOTING SITUATIONS
The following table lists situations that may occur during normal use of the ventilation system that
do not have an alarm associated with them. The possible causes and options for resolving these
situations are also listed.
Additional Troubleshooting Situations
Observation Cause Possible Resolution
Breath indicator
light is not flashing
with the patient’s
breathing.
•Patient’sbreathistooshallow
to trigger augmentation.
•Changethetriggersensitivity
setting to a lower setting.
•Secretionsmayhavebuiltup
on the pillows of the interface,
blocking delivery of air.
•Inspectandcleantheinterface
per the instruction for cleaning
the interface.
•Patientismouthbreathing. •Instructpatienttobreathein
through their nose (purse lipped
breathing is acceptable).
Medium-Priority Alarms

30
29
4AlArms And TroubleshooTing
Breath indicator light
is not flashing.
•AventilatorActivity button has
not been pressed.
•Secretionsmayhavebuiltup
on the pillows of the interface,
blocking delivery of air.
•PressanActivity button.
•Inspectandcleantheinterface
per the instruction for cleaning
the interface.
Buzzer sounds
continuously at a
constant pitch for
two minutes or more.
•Theventilatorbatteryis
internally disconnected.
•Thebackupbuzzerwillsound
for two to five minutes before it
is silenced.
•Contactyourhealthcare
provider.
Gas delivery is
causing coughing or
irritation in airway.
•Interfaceisnotpositioned
correctly.
•Ifsymptomspersist,stop
treatment with the ventilator,
and contact your physician.
No volume output. •Oxygensupplyisdisconnected.
•Oxygensupplyisempty.
•Ventilatorisnoton.
•Batteryisdepleted.
•Ventilatorisinoperative.
•Reconnecttheoxygensupply.
•Replacetheoxygensupply.
•Turntheventilatoron.
•Rechargethebattery.
•Ifthereisnovolumeoutput,
contact your health care
provider.
Oxygen supply does
not last as long as
expected.
•Userbreathrateishigherthan
expected.
•Oxygensupplyisnotfullatthe
start of use.
•Thegasregulatorisnotproperly
connected to the oxygen
cylinder.
•Obtainanewoxygensupply.
•Reconnectthegasregulatorto
the oxygen cylinder.
Ventilator battery
does not last as long
as expected after a
recharge.
•Batteryisnotcharged
completely.
•Batterylifeisnearingitsend.
•Batteryhasbecomeuntrained.
•Rechargebattery.
•Contactyourhealthcare
provider.
•Retrainthebattery,asshownin
section 5.
Ventilator is
autocycling
(delivering gas
without being
triggered by the
patient’s breathing
or delivering gas
multiple times during
one breath).
•Secretionshavebuiltuponthe
pillows of the interface.
•Ventilatoristriggeredby
movement of the interface.
•Ventilatorisinbreath
timeout mode, with timeout
augmentation set to 12 BPM.
•Inspectandcleantheinterface
per the instruction for cleaning
the interface.
•Adjusttriggersensitivitytoa
higher number.
Ventilator is
triggering during
exhalation.
•Secretionshavebuiltuponthe
pillows of the interface.
•Inspectandcleantheinterface
per the instruction for cleaning
the interface.
Ventilator sometimes
misses breaths.
•Userisbreathingfasterthan
40 BPM.
•Secretionshavebuiltuponthe
pillows of the interface.
•Itisnormalfortheventilatorto
limit augmentation to less than
40 BPM.
•Inspectandcleantheinterface
per the instruction for cleaning
the interface.
Ventilator sounds
like it is triggering,
but no gas is being
delivered.
•Nooxygensupplyisconnected. •Reconnectoxygensupply.
Observation Cause Possible Resolution Observation Cause Possible Resolution
Additional Troubleshooting Situations

32
5
CHAPTER
SETUP AND CARE
This section describes how to change settings using the Utilities
menu and instructions on basic care of the system.
ChangingVentilatorSettings
SettingTimeandDate
Setting Vibration Mode
SettingAudioLoudness
AdjustingScreenBrightness
Viewing Software Version Information
CaringfortheNIOVVentilationSystem
Battery Retraining and Replacement
Oxygen Supply Information
This section describes how to change
settings using the Utilities menu and display
the Information screen, which shows the
ventilator software version and the total time
the ventilator has been in use. This section
also gives instructions on basic care of the
ventilation system.
CHANGING VENTILATOR
SETTINGS
WiththeUtilities menu, you can change
the time and date, brightness of the touch
screen, volume of audible alarms, and set
alarms to vibrate mode.
Getting to the Utilities Menu
1On any ventilator screen, touch the
Wrench button.
2On the Menu screen, touch Settings.
3On the Settings Menu screen, touch
Utilities. (The Clinician’s Settings menu
is for clinician use only.)

34
33
5setup and care
SETTING TIME AND DATE
1On the Utilities Menu screen, touch Set
Time/Date.
2On the Set Time/Date screen, touch the
box you want to change.
3Touch the Up arrow to increase the
value in the box or the Down arrow to
decrease it. If you press and hold an
arrow, the value automatically increases
or decreases.
4Repeat steps 2and 3for each box you
want to change, and then touch OK.
6In the message asking if the settings are
OK, touch Confirm.
Note:Changestosettingsonlytake
effect when you touch Confirm.
SETTING VIBRATION MODE
The Set Vibration screen lets you change
alarms from audible tones to a vibration.
However, if a low- or medium-priority
vibrating alarm occurs and is not resolved
in 60 seconds, an audible alarm occurs.
For a high-priority alarm, an audible tone
immediately occurs with a vibration alarm
with no delay.
1On the Utilities Menu screen, touch
Set Vibration.
2On the Set Vibration screen, touch On
or Off.
3 Whenyouarenished,touchOK.
4In the message asking if the settings
are OK, touch Confirm, and check that
the Vibrate icon appears at the
bottom of the touch screen, indicating the
ventilator is in vibrate mode.
Note:Changestosettingsonlytake
effect when you touch Confirm.