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Harmony
User Manual
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Respironics Harmony User Manual

www.r es p i ron i c s .co m
User Manual
BiPAP systems are the subject of one or more patents: U.S. Patents #5148802, #5239995, #531937, #5433193; Canadian Patent #2, 024,477; European Patent #EP0425092; German Patent #6902161681.5-08; and other pending U.S. and foreign patents. BiPAP, Harmony, Encore and SmartCard are registered trademarks of Respironics, Inc.
© 2003 Respironics, Inc. All rights reserved.
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TABLE OF CONTENTS
CHAPTER 1: PACKAGE CONTENTS ........................................................................... 4
CHAPTER 2: WARNINGS AND CAUTIONS ................................................................. 5
2.1 WARNINGS ................................................................................................5
2.2 CAUTIONS ................................................................................................. 6
2.3 INTENDED USE .......................................................................................... 6
2.4 CONTRAINDICATIONS .................................................................................7
2.5 PRECAUTIONS ............................................................................................ 7
2.6 INDUSTRY CANADA NOTICE ....................................................................... 8
CHAPTER 3: INTRODUCTION TO THE HARMONY ....................................................... 9
3.1 DEFINITIONS ..............................................................................................9
3.2 WHAT IS THE HARMONY?........................................................................ 10
3.2 WHAT IS THE HARMONY?........................................................................ 11
3.3 SYMBOLS ................................................................................................. 12
3.4 HOW TO CONTACT RESPIRONICS .............................................................. 12
CHAPTER 4: HARMONY CONTROLS AND
DISPLAY FEATURES ........................................................................................ 13
4.1 PRESSURE ON/OFF BUTTON.................................................................... 13
4.2 HARMONY CONTROL PANEL ................................................................... 13
4.2.1 CONTROL KEYS ............................................................................. 14
4.2.2 ALARM AND POWER INDICATORS ...................................................15
4.2.3 DISPLAY SCREEN ........................................................................... 15
4.2.4 BREATHING CIRCUIT CONNECTION ................................................ 18
4.2.5 REAR PANEL ................................................................................. 18
CHAPTER 5: SETTING UP THE HARMONY ............................................................... 20
5.1 INSTALLING THE AIR FILTERS ................................................................... 20
5.2 WHERE TO PLACE THE HARMONY ........................................................... 21
5.3 CONNECTING THE BREATHING CIRCUIT .................................................... 21
5.4 COMPLETE HARMONY SETUP ................................................................... 23
5.5 PLUGGING THE HARMONY IN .................................................................. 24
5.5.1 USING AC POWER ........................................................................ 24
5.5.2 USING DC POWER ........................................................................ 24
CHAPTER 6: OPERATING THE HARMONY .............................................................. 26
6.1 STARTING THE HARMONY ........................................................................ 26
6.2 CHANGING THE DEVICE SETTINGS ........................................................... 28
6.2.1 CHANGING THE HUMIDIFIER SETTING ............................................ 29
6.2.2 NAVIGATING THE USER DISPLAY SCREENS ...................................... 30
6.2.2.1 CHANGING THE FLEX SETTING ............................................ 31
6.2.2.2 CHANGING THE RISE TIME SETTING .................................... 31
6.2.2.3 CHANGING THE RAMP STAR TING PRESSURE ......................... 32
6.2.2.4 CHANGING THE LED BACKLIGHT SETTING .........................33
CHAPTER 7: HARMONY ALARMS ...........................................................................34
7.1 INTRODUCTION TO ALARMS ..................................................................... 34
7.2 WHAT TO DO WHEN AN ALARM OCCURS ............................................... 35
7.3 ALARM TABLES ....................................................................................... 37
7.3.2 MEDIUM PRIORITY ALARMS ........................................................... 38
7.3.3 LOW PRIORITY ALARMS ................................................................. 38
CHAPTER 8: TROUBLESHOOTING ............................................................................39
CHAPTER 9: CLEANING AND MAINTENANCE ........................................................ 41
9.1 CLEANING THE HARMONY .......................................................................41
9.2 CLEANING OR REPLACING THE INLET FILTERS ..........................................41
CHAPTER 10: ACCESSORIES .................................................................................. 44
10.1 ADDING A HUMIDIFIER .......................................................................... 44
10.2 ADDING OXYGEN TO THE HARMONY ..................................................... 44
CHAPTER 11: SPECIFICATIONS ............................................................................... 45
ENVIRONMENTAL ........................................................................................... 45
PHYSICAL ...................................................................................................... 45
ELECTRICAL ...................................................................................................45
PRESSURE ...................................................................................................... 46
CONTROL ACCURACY .................................................................................... 46
INDEX ...................................................................................................................47
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CHAPTER 1: PACKAGE CONTENTS
Your BiPAP Harmony should include the following items. If any of these items are missing, contact your home care provider.
BiPAP Harmony with
Encore
®
Filter Cap
Pro SmartCard
Power Cord
®
Ultrafine Filter
Pollen Filters
www.re spironics.com
User Manual
Flexible Tubing
6 ft. (1.83 m) X 22 mm i.d.
External AC Power Supply
CHAPTER 2: WARNINGS AND CAUTIONS
WARNING: Indicates the possibility of injury to the user or operator.
CAUTION: Indicates the possibility of damage to the device.
NOTE: Places emphasis on an operating characteristic.
2.1 WARNINGS
• This manual serves as a reference. The instructions in this manual are not intended to supersede the instructions of your health care provider.
•You should read and understand this entire manual before using the Harmony.
• The Harmony is not intended to provide your total ventilatory requirement.
• The prescription must only be adjusted by a trained home care provider.
• Use only the breathing circuit provided by your home care provider.
• When using a breathing circuit that contains a mask with an integrated exhalation port or a circuit with a separate exhalation device, do not tape, seal, or otherwise block the vent openings. Doing so could result in suffocation.
• If oxygen is used with the Harmony, the oxygen flow must be turned off when the Harmony is not in use.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.
• Do not use the Harmony in the presence of flammable liquids or gases. Do not clean the Harmony with flammable fluids.
• Do not use the Harmony if the room temperature is above 95º F
(35°C). If the device is used at room temperatures above 95° F, the temperature of the airflow may exceed 106º F (41°C), which
could cause irritation to your airway.
• Do not operate the Harmony in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the Harmony.
• When the Harmony is used with a humidifier, position the humidifier so that the water level in the humidifier is lower than you and the humidifier is on the same level or lower than the Harmony.
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• If you detect any unexplained changes in the performance of the Harmony, if the device is dropped or mishandled, or if the enclosure is broken, seek the assistance of your home care provider.
• If water is spilled into the enclosure, discontinue use of the Harmony and remove the power cord. Pour out the excess liquid and allow the unit to dry out. If the device does not function properly, contact your home care provider.
• Repairs and adjustments must be performed by Respironics ­authorized service personnel only. Unauthorized service 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 before cleaning it.
2.2 CAUTIONS
CAUTION! US federal law restricts this device to sale by or on the
order of a physician.
• The Harmony may only be operated at temperatures between
41º F (5°C) and 95º F (35°C).
•A properly installed, undamaged reusable foam inlet filter is required for proper operation.
• Do not immerse the Harmony or allow any liquid to enter the enclosure or the inlet filter.
• Condensation may damage the Harmony. Always allow the Harmony to reach room temperature before use.
Additional warnings, cautions, and notes are located throughout this manual.
2.3 INTENDED USE
The Harmony is intended to provide noninvasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condi­tion in which the patient can continue without ventilation for some period of time, such as overnight) or obstructive sleep apnea. This device may be used in the hospital or home.
The Harmony is intended for use with nasal masks and full-face masks as recommended by Respironics.
2.4 CONTRAINDICATIONS
The Harmony 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:
• Inability to maintain a patent airway or adequately clear
secretions
• At risk for aspiration of gastric contents
• Diagnosed with acute sinusitis or otitis media
• Allergy or hypersensitive to the mask materials where the risk
from allergic reaction outweighs the benefit of ventilatory assistance
• Epistaxis, causing pulmonary aspiration of blood
• Hypotension
2.5 PRECAUTIONS
•Immediately report any unusual chest discomfort, shortness of breath, or severe headache.
• If skin irritation or breakdown develops from the use of the mask, refer to the mask instructions for appropriate action.
• The following are potential side effects of noninvasive positive pressure therapy:
— Ear discomfort
— Conjunctivitis
— Skin abrasions due to noninvasive interfaces
— Gastric distention (aerophagia)
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2.6 INDUSTRY CANADA NOTICE
NOTICE: The Industry Canada Label identifies certified equipment. This certification means that the equipment meets telecommunications network protective, operational, and safety requirements as prescribed in the appropriate Terminal Equipment Technical Requirements docu­ments. The Department does not guarantee the equipment will operate to the user’s satisfaction.
Before installing this equipment, users should make sure that it is permissible to be connected to the facilities of the local telecommunica­tions company. The equipment must also be installed using an accept­able method of connection. The customer should be aware that compli­ance with the above conditions may not prevent degradation of service in some situations.
Repairs to certified equipment should be coordinated by a representa­tive designated by the supplier. Any repairs or alterations made by the user to this equipment, or equipment malfunctions, may give the telecommunications company cause to request the user to disconnect the equipment.
Users should ensure for their own protection that the electrical ground connections of the power utility, telephone lines and internal metallic water pipe system, if present, are connected together. The precaution may be particularly important in rural areas.
CAUTION: Users should not attempt to make such connections
themselves, but should contact the appropriate electric inspection authority, or electrician, as appropriate.
Ringer Equivalence Number (REN): The REN assigned to each termi­nal device provides an indication of the maximum number of terminals allowed to be connected to a telephone interface. The termination on an interface may consist of any combination of devices subject only to the requirement that the sum of the Ringer Equivalence Numbers of all the devices does not exceed 5.
CHAPTER 3: INTRODUCTION TO THE HARMONY
This chapter contains the following information:
• Definitions for common terms used throughout this manual
• An overview of the Harmony device
• An explanation of the symbols used on the Harmony and throughout this manual
• Contact information
3.1 DEFINITIONS
The following terms appear throughout this manual:
Apnea A condition marked by the cessation of
spontaneous breathing.
CPAP Continuous Positive Airway Pressure
EPAP Expiratory Positive Airway Pressure
High Priority Alarm Alarm signal indicating a condition that
requires immediate attention
IPAP Inspiratory Positive Airway Pressure
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Low Priority Alarm Signal indicating an information message
Medium Priority Alarm Alarm signal indicating a condition that
requires operator awareness
Operate State The state of the Harmony device when the
unit and the blower are both on.
Standby State The state of the Harmony device when the
unit is on, but the blower is off.
OSA Obstructive Sleep Apnea
Patient Disconnect Alarm This event occurs when the device detects a
larger circuit leak. The event terminates when the circuit leak returns to normal limits or when initiated by the user.
Ramp A feature that may increase patient comfort
when therapy is started. The Harmony IPAP starts at the EPAP level and is increased gradually (breath by breath over several breaths) until the IPAP prescription pressure is reached.
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Rise Time The time it takes for the Harmony to change
from EPAP to IPAP. You can adjust this time for your comfort.
RR Respiratory Rate
Spontaneous (S) A bi-level mode which responds to both your
inhalation and exhalation by increasing pressure when you start to inhale and de­creasing pressure when you start to exhale. There is no automatic delivery of a breath should you not inhale.
Spontaneous/ A bi-level mode which responds to both your Timed (S/T)
inhalation and exhalation by increasing pressure when you start to inhale and de­creasing pressure when you start to exhale. If you do not start inhaling within a set time, the Harmony automatically starts inhalation. When the Harmony starts inhalation, it controls the time of inhalation and automati­cally decreases the pressure for exhalation within a set time.
3.2 WHAT IS THE HARMONY?
The Harmony, shown in Figure 3–1, supplies air pressure through a breathing ciruit.
Figure 3–1 The Harmony
The circuit, shown in Figure 3–2, consists of:
•Circuit tubing to deliver air from the Harmony to your interface (e.g., mask)
•A mask or other interface to deliver the prescribed pressure to your nose or nose and mouth, depending on which interface has been prescribed for you
• An exhalation port to vent exhaled air from the circuit
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Patient Interface
Circuit with Separate
Exhalation Device
(Typical)
Exhalation Device
(Typical)
Circuit
Tubing
Circuit with Mask with
Integrated Exhalation Ports
Exhalation Ports
(one port on each side of elbow)
Figure 3–2 Typical Breathing Circuits
NOTE: The exhalation port may be part of the mask or may be part of
a separate exhalation device.
The system senses your breathing effort and changes pressure levels when you inhale and exhale depending on the mode of operation.
The Harmony can operate on AC or DC power. The DC power option is not intended as a battery backup. When DC power is obtained from a vehicle battery, the Harmony should not be used while the vehicle’s engine is running.
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3.3 SYMBOLS
The symbols shown below are used on the Harmony and throughout this manual.
Symbol Meaning
Attention, consult accompanying documents
DC Power
Type BF Applied Part
Class II (Double Insulated)
European CE Declaration of Conformity
Notified Body Approval for Standards Compliance
Canadian/US Certification
3.4 HOW TO CONTACT RESPIRONICS
To have your unit serviced, contact your home care provider. If you need to contact Respironics directly, call 1-800-345-6443 or use the following address:
CHAPTER 4: HARMONY CONTROLS AND
DISPLAY FEATURES
Figure 4–1 shows the location of the Harmony’s control panel, Pressure On/Off button, and breathing circuit connection.
Control Panel
Breathing Circuit
Connection
Pressure On/Off
Button
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Figure 4–1 Harmony Front and Top
4.1 PRESSURE ON/OFF BUTTON
The Harmony’s Pressure On/Off button, located on the side of the unit, starts and stops the unit’s airflow. Press the button in to turn the airflow on. This puts the Harmony in the Operate state. Depress the button to turn the airflow off and put the Harmony in the Standby state.
When the Harmony is in Standby, any ramp in progress is terminated, the alarms are reset (except for the System Errors alarm), and the humidifier is turned off.
The Pressure On/Off button is independent of the display screen.
4.2 HARMONY CONTROL PANEL
The control panel contains the following control keys and indicators.
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4.2.1 CONTROL KEYS
The control keys on the control panel are shown in Figure 4–2.
Display Screen
Alarm Reset Button
Alarm Silence Button
Heated
Humidifier
Button
HEAT
RAMP
Ramp
Button
User
Buttons
RESET
SILENCE
Figure 4–2 Harmony Control Panel
HEAT When the optional REMstar or H2 heated humidifier is
prescribed, this button controls the humidifier’s output. Follow the instructions provided with the humidifier. When a humidifier is not in use, this button can be used to adjust the parameters shown in the user menu screens.
RAMP When the airflow is turned on, this button lowers the
airflow pressure, allowing you to fall asleep more easily. When the airflow is turned off, this button can be used to adjust the parameters shown in the user menu screens.
USER The left and right user buttons allow you to navigate the
display screens.
SILENCE This button silences the audible portion of an alarm for
one minute.
RESET This button allows you to clear an alarm and reset the
device for alarm detection.
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