Respironics Bipap Harmony S/T User manual

S/T
P
atient Guide

1004221
JR 3/15/01

1
S/T Patient Guide
Contents
Warnings, Cautions, and Notes .................................................................... 3
Warnings ............................................................................................................................................................ 3
Cautions............................................................................................................................................................. 4
Temperatures ..................................................................................................................................................... 4
Intended Use/Indications for Use ....................................................................................................................... 5
Contraindications ............................................................................................................................................... 5
1 Contents of the Package........................................................................... 6
2 Introduction to the Harmony S/T.............................................................. 7
What is Bi-Level Ventilation?..............................................................................................................................7
What is the Harmony S/T? ................................................................................................................................. 8
Symbols ............................................................................................................................................................. 9
How to Contact Respironics............................................................................................................................... 9
3 A Tour of the Harmony S/T ..................................................................... 10
Overview .......................................................................................................................................................... 10
Top Panel ......................................................................................................................................................... 11
Connecting the Breathing Circuit ..................................................................................................................... 12
Rear Panel ....................................................................................................................................................... 12

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S/T Patient Guide
4 Using the Harmony S/T ........................................................................... 13
Installing the Inlet Filters .................................................................................................................................. 13
Where to Place the Harmony S/T Unit ............................................................................................................. 14
Connecting the Breathing Circuit ..................................................................................................................... 14
Complete Harmony S/T Setup ......................................................................................................................... 16
Plugging the Unit In (UsingAC Power) ............................................................................................................ 17
Using DC Power............................................................................................................................................... 17
Starting the Harmony S/T Unit ......................................................................................................................... 18
Adjusting the Rise Time ................................................................................................................................... 18
5 Alarms and What to Do............................................................................. 19
6 Troubleshooting ...................................................................................... 23
Mask Discomfort and Corrective Actions ......................................................................................................... 24
7 Cleaning the Unit and Filters ................................................................... 27
Cleaning Your Harmony Unit............................................................................................................................ 27
Cleaning/Replacing the Inlet Filters ................................................................................................................. 28
8 Using Oxygen with your Harmony Ventilator ....................................... 30
Limited Warranty.......................................................................................... 35

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S/T Patient Guide
Warnings, Cautions, and Notes
Warnings
AWarning indicates the possibility of injury to you or the
operator of the device.
• This manual serves as a reference. The instructions in
this manual are not intended to supersede the
instructions of your care giver.
• The Harmony S/T ventilator is not intended to provide
the total ventilatory requirements of the patient.
• The prescribed patient settings must be adjusted by
trained and authorized personnel only. Do not attempt
to open the top lid of the unit.
• Use only the patient circuit provided by your home
care provider.
• When using a patient circuit that contains a Whisper
Swivel®II or other exhalation device, do not tape, seal,
or otherwise block the vent openings. Doing so may
result in asphyxia.
• Oxygen supports combustion. Oxygen should not be
used while smoking or in the presence of an open flame.
• Exercise caution when using the Harmony S/T ventilator
if the room temperature is greater than 95 °F (35 °C). At
high room temperatures, the air from the unit can cause
discomfort or irritation to your nasal passages and your
airway.
•Do not use the Harmony S/T if the breathing circuit
connection is blocked.
• When the Harmony S/T ventilator is used with a
humidifier, be sure that the humidifier is lower than both
the unit and you.
• Repairs and adjustments must be performed by
Respironics-authorized service personnel ONLY.
Service done by inexperienced, unqualified personnel or
installation of unauthorized parts could cause injury,
invalidate the warranty, or result in costly damage.
• Periodically inspect electrical cords for damage or signs
of wear.
• To avoid electrical shock, unplug the Harmony S/T unit
before cleaning it.
• Immediately report any unusual chest discomfort,
shortness of breath, or severe headache to
your physician.
• If the unit is dropped or if you notice any changes in the
operation, contact your home care provider.
WARNINGS

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S/T Patient Guide
Additional Warnings, Cautions, and Notes are
located throughout this manual.
Cautions, Notes
Cautions
A Caution indicates the possibility of damage to the device.
• Federal law restricts this device to sale by or on the order
of a physician.
• Do not expose the Harmony S/T ventilator to tempera-
tures at or near the extremes of those shown below. If
exposure to such temperatures has occurred, allow the
unit to come to room temperature before turning it on.
Temperatures
Operating: 5 °C to 40 °C
Transport/Storage: -20 °C to 60 °C
• The unit must be positioned on its base for
proper operation.
• Do not place the unit such that any side or the bottom of
the unit may not have adequate air circulation.
• A properly installed, undamaged inlet filter is required
for proper operation.
• Never place liquids on or near the Harmony S/T unit.
• If the External Battery Discharged Alarm is activated,
disconnect the external battery immediately.A dis-
charged battery may be damaged if it continues to be
connected to the ventilator.

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S/T Patient Guide
Intended Use/Indications for Use
The BiPAP Harmony S/T is a non-invasive, pressure
support ventilator used to augment the breathing of
patients suffering from acute or chronic respiratory
insufficiency, or to maintain airway patency and provide
ventilatory support to patients who experience obstructive
sleep apnea.
It is not intended to provide the total ventilatory
requirements of the patient.
The Harmony S/T is intended for use in the home,
hospital, or other institutional settings.
Contraindications
The Harmony S/T ventilator should not be used if you
have severe respiratory failure without a spontaneous
respiratory drive.
If any of the following conditions apply to you, consult
your physician before using the Harmony S/T ventilator.
Consult your physician if you have:
• the inability to maintain a patent airway or adequately
clear secretions.
• a risk of aspiration of gastric contents.
• acute sinusitis or otitis media.
• an allergy or hypersensitivity to the mask materials
where the risk
from allergic reaction outweighs the benefit of ventila-
tory assistance.
• epistaxis.
• hypotension.
The following are potential side effects of noninvasive
positive pressure therapy:
• Ear discomfort
• Conjunctivitis
• Skin abrasions due to noninvasive interfaces
• Aerophagia (gastric distention)
Intended Use, Contraindications

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S/T Patient Guide
1 Contents of the Package
The BiPAP Harmony S/T package contains:
• BiPAP Harmony S/T unit
• Six feet of tubing
• Whisper Swivel II exhalation port
• Gray Foam filter
• Ultra-fine filter
If any of the items are missing, please contact your home
care provider.
Disposable
Ultra-fine Filter
Harmony S/T Unit Six Feet of
Tubing
Exhalation
Port
Package Contents
Your home care provider should have pre-assembled the
tubing, exhalation port, and mask into a breathing circuit.
OPTIONS
• DC power cord
• Oxygen valve (required for oxygen use)
• Bacteria filter
• Humidifier
Reusable Gray
Foam Filter

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S/T Patient Guide
2 Introduction to the Harmony S/T
What is Bi-Level Ventilation?
Bi-level ventilation with the Harmony S/T Ventilatory
Support System helps you to breathe by supplying two
levels of air pressure. The Harmony S/T provides a higher
pressure—known as IPAP (Inspiratory PositiveAirway
Pressure)—when you inhale, and a lower pressure—
known as EPAP(Expiratory Positive Airway Pressure)—
when you exhale. The higher pressure opens your airway
to increase the amount of air going into your lungs, and the
lower pressure makes it easier for you to exhale while still
keeping your airway open.
NOTE:Occasionally, cosmetic changes may be made to
the product that do not affect the performance or
specifications of the product. These kinds of
changes do not warrant a reprinting of this
manual. Illustrations are for reference only.
Introduction
IPAP
Pressure
EPAP
Pressure
The Harmony Ventilator Provides
Two Levels of Ventilation.
Figure 2-1. BiPAP Breathing Levels.

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S/T Patient Guide
What is the Harmony S/T?
The Harmony ventilator, shown in Figure 2-2, supplies
two levels of air pressure through a breathing circuit. The
circuit consists of:
• circuit tubing to deliver the air from the ventilator to
your interface (e.g., mask)
• an exhalation port to vent exhaled air from the circuit
• a mask or other interface to deliver the ventilation to
your nose or nose and mouth, depending on which
interface has been prescribed for you
The system senses your breathing effort and changes
pressure levels when you inhale and exhale.
Figure 2-2. The Harmony S/T Unit.
Introduction

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S/T Patient Guide
Symbols
The symbols shown at right are used on the Harmony S/T
and throughout this manual.
How to Contact Respironics
To have your unit serviced, contact your home care
provider. If you need to contact Respironics directly, use
the following addresses:
Attention, consult accompanying documents
AC Power Indicator
DC Power Indicator
Alarms
System Alarm Indicator
Patient Alarm Indicator
START
STOP
Time at Pressure
Rise Time control (patient comfort)
Type BF
Symbol Meaning
Symbols

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S/T Patient Guide
3 A Tour of the Harmony S/T
Overview
Figure 3-1 shows the location of the:
• controls and indicators
• breathing circuit connection
• carry handle
Controls/
Indicators
Carrying
Handle
Breathing Circuit
Connection Optional Oxygen
Valve
Tour of the Harmony S/T
Figure 3-1. The Harmony S/T Front and Top.

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S/T Patient Guide
Top Panel
The top panel contains the controls and indicators you will
need when you are using the BiPAP Harmony S/T.
• Start/Stop switch
• AC Power Indicator
• DC Power Indicator
• Patient Alarm
• System Alarm
• Rise Time control
The Start/Stop switch starts and stops the unit.
The AC and DC power indicators show you whether the
Harmony S/T is connected toAC or DC power.
The Patient and System alarms alert you when a problem
occurs. See Chapter 5 for an explanation of what to do
when an alarm is activated.
The Rise Time control adjusts the time the pressure takes
to go from the lower-level pressure (EPAP) to the
higher-level pressure (IPAP). You adjust this control for
your comfort.
¤
Rise Time
Control
Alarm
Indicators
Power
Indicators
Start/Stop
Switch
Pressure
Indicator
Top Panel
Figure 3-2. The Harmony S/T Top Panel.
The controls and indicators contained within the dotted
line in Figure 3-2 are covered by a door that prevents the
settings from being accidentally changed. Your home care
provider has set the controls according to
your prescription.
The Pressure Indicator and the IPAP and EPAPslides are
visible through the window of the door. The Pressure
Indicator shows the approximate pressure level produced.
The IPAPand EPAP slides light when the unit is in the
respective phase of therapy.

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S/T Patient Guide
Connecting the Breathing Circuit
Figure 3-3 shows where the circuit tubing connects to the
Harmony S/T unit.
Rear Panel
Figure 3-4 shows the location of the:
• air inlet filters
• AC inlet
• DC inlet
The Harmony S/T uses a gray pollen filter that is
washable and reusable, and a white ultra-fine filter that
is disposable.
The AC Inlet is where the AC receptacle is connected if
you are running the unit from house voltage.
DC Inlet
AC Inlet
DC Cord
Retainer
Filter Access
Panel
Circuit Connections, Rear Panel
The DC Inlet is where the DC plug is connected if you are
running the unit from a 12 Vdc source.
Patient
Interface
Port
Figure 3-3. Breathing Circuit Connection.
Figure 3-4. Rear Panel.

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S/T Patient Guide
4 Using the Harmony S/T
Installing the Inlet Filters
The Harmony uses a gray foam filter that is reuseable, and
an optional white ultra-fine filter that is disposable. One
filter of each kind is supplied with Harmony.
If your home care provider did not install the inlet filters,
you must install at least the gray foam filter before using the
Harmony.
STEP 1 Place the pollen filter on top of the
ultra-fine filter.
STEP 2 Slide the filters into the air inlet at the rear of the
unit.
STEP 3 Place the bottom of the inlet filter cover into the
bottom of the air inlet opening, making sure that
the catches engage the lip of the opening.
STEP 4 Swing the top of the cover into place and press
down on it to engage the cover catches in the air
inlet opening.
See Chapter 7 for instructions to clean or replace the filters.
Reusable Pollen
Filter
Disposable Ultra-fine
Filter
Inlet Filter
Cover
Installing the Air Filters

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S/T Patient Guide
Where to Place the Harmony S/T Unit
Place the Harmony S/T unit on its base somewhere within
easy reach of where you will be using it. Make sure that
the air inlet on the rear of the unit is not blocked. If you
block the air flow around the unit, the unit may not work
properly.
If you are using a humidifier, be sure to place the
humidifier and unit on a placemat or other waterproof
material to protect your furniture from moisture. Both you
and the Harmony S/T ventilator MUST be positioned
higher than the humidifier to prevent the backflow of water
into the unit or into your mask.
STEP 1 Connect one end of the six-foot tubing to the
large connector on the Harmony unit.
STEP 2 Connect the open end of the circuit tubing to the
exhalation device.
Connecting the Breathing Circuit
Circuit
Tubing
Exhalation
Device
Circuit
Tubing
Step 1
Step 2
Placing the Harmony S/T for Use

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S/T Patient Guide
STEP 3 Connect the exhalation device to the mask
connector.
STEP 4 Attach the Softcap®or headgear to the mask—
see the instructions that came with your Softcap
or headgear.
Exhalation
Device
Mask
Connector
Mask or
Other
Interface
Step 3
Connecting the Breathing Circuit

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S/T Patient Guide
Complete Harmony S/T Setup
Figure 4-1 shows the completed breathing circuit setup for
the Harmony S/T unit.
Circuit
Tubing
Exhalation
Port
Patient
Interface
(typical)
Complete Setup
Figure 4-1. Harmony S/T Complete Breathing Circuit.

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S/T Patient Guide
Plugging the Unit In (Using AC Power)
STEP 1 Plug the receptacle end of the AC cord into the
AC inlet.
STEP 2 Insert the plug end of theAC cord into the wall
outlet.
WARNING: Never plug the Harmony S/T AC cord into
an outlet that is controlled by a
wall switch.
If the External Battery Discharged Alarm is activated,
disconnect the external battery immediately. Adischarged
battery may be damaged if it continues to be connected to
the ventilator.
Using DC Power
Plugging the Unit In
DC Cord
Retainer
STEP 1 Plug the receptacle end of the DC cord into the
DC inlet.
STEP 2 Leaving some slack in the DC cord, push the
DC cord into the DC cord retainer.
STEP 3 Insert the adaptor end of the DC cord into the
appropriate DC outlet. See the instructions that
came with the DC cord for proper DC
connections.

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S/T Patient Guide
Starting the Harmony S/T Unit
STEP 1 Press the Start/Stop switch to the START
position. The unit will sound two beeps and
briefly illuminate all the indicators. This is the
internal test performed by the unit.
STEP 2 Allow the unit to establish flow and then put on
your mask assembly.
NOTE: If the unit does not sound the two beeps or
illuminate the indicators, do not try to use the
unit. Contact your home care provider.
STEP 3 Make sure that no air is leaking from your mask
into your eyes. If it is, adjust the mask and
Softcap or headgear until air stops leaking into
your eyes. See the instructions that came with
your mask.
STEP 4 If you are using the Harmony while sleeping,
place the tubing from the Harmony unit over
your headboard to reduce tension on the mask.
NOTE: A small amount of mask leak is normal and
acceptable. Large mask leaks or eye irritation
from an air leak should be corrected as soon as
possible.
Starting the Unit
STEP 5 Relax. Take slow, relaxed breaths through
your nose.
NOTE: If you are having trouble with your mask, see
Chapter 6 for some suggestions.
Adjusting the Rise Time
The Rise Time is the time it takes for the Harmony to
change from EPAP to IPAP (See Chapter 2). You can
adjust this time to meet your comfort needs by moving the
Rise Time control (See Figure 3-2). The control changes
from a faster rise time on the left to a slower rise time on
the right.